ARROW INTERNATIONAL Inc. recalls
Every recall we track for ARROW INTERNATIONAL Inc. — 366 in all, from 2017–2024 — plus the complaints and injury reports the public filed about them. 21 are rated “stop using now”.
Recalls per year, by danger level
Recalls from ARROW INTERNATIONAL Inc. dropped to zero in 2025 (0, down from 5 in 2024). 6% rated “stop using now”.
All FDA recall records for ARROW INTERNATIONAL Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 4 | 8 | 57 | 0 | 69 |
| 2018 | 9 | 3 | 98 | 0 | 110 |
| 2019 | 2 | 0 | 64 | 0 | 66 |
| 2020 | 6 | 52 | 4 | 2 | 64 |
| 2021 | 0 | 5 | 1 | 4 | 10 |
| 2022 | 0 | 24 | 9 | 2 | 35 |
| 2023 | 0 | 1 | 6 | 0 | 7 |
| 2024 | 0 | 4 | 1 | 0 | 5 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for ARROW INTERNATIONAL Inc. recalls
What to do if you have a recalled ARROW INTERNATIONAL Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All ARROW INTERNATIONAL Inc. recalls
53 shown- Lower riskMedical device
ARROW INTERNATIONAL Inc. recalls Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not
Arrow recalls 15 specific arterial kits and trays due to open seals on packaging. Consumers should check product references and batch numbers to determine if affected.
ArrowJul 26, 2024 - Use cautionMedical device
ARROW INTERNATIONAL Inc. recalls Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
Arrow recalls specific models of FiberOptix Intra-Aortic Balloon Catheter Kits due to potential failure to inflate fully, damaged segments, or helium loss/blood in pathways, which could cause serious health issues.
ArrowApr 29, 2024 - Use cautionMedical device
ARROW INTERNATIONAL Inc. recalls ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF
ARROW recalls specific radial artery catheter models due to potential guidewire handle resistance causing arterial spasms or vessel injury from repeated punctures. Affected units have listed part numbers and lot numbers.
ARROWFeb 12, 2024 - Lower riskMedical device
ARROW INTERNATIONAL Inc. recalls Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker
Arrow recalls ErgoPack Pressure Injectable Arrowg+ard Blue Advance kits with incorrect labeling on lidstock. Affected kits have a specific batch number and style. Contact Arrow for details.
ArrowAug 10, 2023 - Lower riskMedical device
ARROW INTERNATIONAL Inc. recalls Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Arrow recalls ErgoPack Pressure Injectable One-Lumen PICC kits with incorrect labeling on lidstock. Affected kits may have mislabeled product codes, but no safety risk exists.
ArrowAug 10, 2023 - Use cautionMedical device
ARROW INTERNATIONAL Inc. recalls ARROW Endurance Extended Dwell Peripheral Catheter System
ARROW recalls specific catheter systems due to potential separation or leakage. Affected models include ASK-00620-MSH, ASK-00620-TMC, and others with unique UDI batch numbers. Stop using if you have these items.
ARROWMay 19, 2023 - UnratedMedical device
ARROW INTERNATIONAL Inc. recalls Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c)
Arrow recalls specific Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kits due to potential inadequate connection between Micro Clave Clear Connectors and the kit, which could lead to improper use.
ArrowOct 27, 2022 - Lower riskMedical device
ARROW INTERNATIONAL Inc. recalls Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
Arrow recalls AutoCAT2 Intra-Aortic Balloon Pumps with potential short battery run-times. Affected units may require replacement due to battery issues.
ArrowOct 17, 2022 - Lower riskMedical device
ARROW INTERNATIONAL Inc. recalls ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF
ARROW recalls a specific midline IV kit due to mislabeled catheter size. This could lead to incorrect use if the wrong catheter is used. Affected units have a specific product code and reference number.
ARROWSep 14, 2022 - Lower riskMedical device
ARROW INTERNATIONAL Inc. recalls Arrow Three-Lumen CVC
Arrow recalls specific models of Three-Lumen CVC due to incorrect gravity flow rates on the lidstock. Affected units may not function properly.
ArrowMay 5, 2022 - Use cautionMedical device
Arrow International Inc recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The
Arrow recalls 7FR Percutaneous Thrombolytic Devices with risk of inner lumen detachment causing embolization. Affected units have specific product codes and lot numbers. Consumers should contact Arrow for details.
ArrowSep 20, 2021 - UnratedMedical device
Arrow International Inc recalls Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for
Arrow recalls a specific pacing catheter kit due to being marketed without proper FDA 510K clearance. This device is used in electrophysiology studies. Affected units have specific lot numbers.
ArrowMay 19, 2021 - Use cautionMedical device
Arrow International Inc recalls Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US)
Arrow recalls OnControl Bone Lesion Biopsy System Tray (Product Code 9464-VC-006) due to difficulty inserting biopsy ejector rod, risking repeat procedures. Affected units sold in US/EU with specific lot numbers.
ArrowMar 8, 2021 - Lower riskMedical device
Arrow International Inc recalls Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the
Arrow recalls AGB+ Multi-Lumen CVC Kits (CDC-45703-1A) due to potential allergic reactions in patients sensitive to chlorohexidine, silver sulfadiazine, or sulfa. Affected kits may have incorrect labeling.
ArrowJan 6, 2021 - Lower riskMedical device
Arrow International Inc recalls Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub
Arrow recalls Cannon II Plus Replacement Hub Set with incorrect expiration dates on labels. Using expired products may increase infection risk. Consumers should check product codes and contact Arrow for details.
ArrowJul 6, 2020 - Use cautionMedical device
Arrow International Inc recalls Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500
Arrow recalls AutoCAT2 Intra-Aortic Balloon Pump models with serial numbers 140861W-151030W to prevent vibration-related motor connector failures that could cause pump alarms or sudden shutdowns.
ArrowMay 20, 2020 - Use cautionMedical device
Arrow International Inc recalls Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA
Arrow recalls FlexTip Plus Epidural Kits with NRFit Connector due to reported rotatable collar detachment causing leaks. Affected units include specific product codes and distribution lots.
ArrowMay 8, 2020 - UnratedMedical device
Arrow International Inc recalls Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter, Product Code ASK-05502-NY
Arrow recalls Epidural Catheterization Kits with FlexTip Plus syringes that may cause dural puncture, requiring blood patches. Affected kits have specific product codes and lot numbers.
ArrowJan 15, 2020 - Lower riskMedical device
Arrow International Inc recalls Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1
Arrow recalls StimuCath Continuous Nerve Block Kit ASK-050:13F18A0547 due to incorrect expiration date on product lidstock. This may lead to improper use of the medical device.
ArrowDec 20, 2019 - Lower riskMedical device
Arrow International Inc recalls Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with
Arrow recalls arterial catheter kits with incorrect MRI safety labeling. The kit may be unsafe for MRI scans due to mislabeled magnetic resonance compatibility.
ArrowDec 12, 2019 - Lower riskMedical device
Arrow International Inc recalls Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
Arrow recalls specific lots of Endurance Extended Dwell Peripheral Catheters due to potential sterility issues. Affected units may not be sterile, risking infection during medical procedures.
ArrowDec 6, 2019 - Stop using nowMedical device
Arrow International Inc recalls Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
Arrow recalls 60cm angiographic catheters with potential balloon extension line leaks that could cause slow deflation or contrast injection into vascular tissue, risking serious injury or death.
ArrowNov 15, 2019 - Lower riskMedical device
Arrow International Inc recalls 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A -
Arrow recalls Blue PSI Kit Cath-Gard for possible incorrect banner card in kit. This may affect catheter use safety. Contact Arrow for details.
ArrowAug 6, 2019 - Lower riskMedical device
Arrow International Inc recalls Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and
Arrow recalls AGB+ Multi-Lumen CVC Kit (CDC-4270:1A) due to incorrect catheter length labeling. This may cause improper use in medical procedures. Contact Arrow for details.
ArrowJul 18, 2019 - Lower riskMedical device
Arrow International Inc recalls Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product
Arrow recalls pediatric two-lumen central venous catheter kits with blue flextip catheters due to a labeling error in the lidstock showing reversed gauge values. This may cause incorrect gauge selection during medical procedures.
ArrowMay 17, 2019 - Lower riskMedical device
Arrow International Inc recalls Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42552 JX1A
Arrow recalls JACC catheters with incorrect expiration dates. Affected units may have safety risks if used beyond the valid date.
ArrowApr 23, 2019 - Lower riskMedical device
Arrow International Inc recalls Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN:
Arrow recalls two-lumen central venous catheter sets with blue flextip catheters due to incorrect priming volume labeling on the lidstock. This may cause errors in medical procedures.
ArrowJan 10, 2019 - Lower riskMedical device
Arrow International Inc recalls Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure
Arrow recalls PICC kits that may contain a 40cm stylet labeled as 50cm or vice versa. This could lead to incorrect use during medical procedures. Affected kits have Product Code CDC-44052-VPS2.
ArrowDec 13, 2018 - Lower riskMedical device
Arrow International Inc recalls Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm,
Arrow recalls pediatric central venous catheter sets with incorrect priming volume and flow rates. Affected units sold in specific lots; contact Arrow for details.
ArrowNov 14, 2018 - Use cautionMedical device
Arrow International Inc recalls AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump
Arrow recalls disposable pain control pumps with possible cracks in fill port connectors that may cause leaks, leading to reduced pain relief and needing extra medication.
ArrowOct 2, 2018 - Lower riskMedical device
Arrow International Inc recalls Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code
Arrow recalls AGB+ Multi-Lumen CVC Kits with inconsistent labeling of spring wire guide size. This may cause confusion in medical use but does not pose a safety risk.
ArrowSep 21, 2018 - Lower riskMedical device
Arrow International Inc recalls Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide
Arrow recalls CVC kits with expired dates due to shipping errors. Using expired kits may affect sterility or function. Check product labels for expiration date.
ArrowAug 30, 2018 - Lower riskMedical device
Arrow International Inc recalls ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow
Arrow recalls bipolar electrode catheters with incorrect expiration dates. Products labeled with wrong use-by date may expire before intended use. Consumers should check product labels for correct expiration date.
ArrowJul 30, 2018 - Lower riskMedical device
Arrow International Inc recalls 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code
Arrow recalls two PICC kits that may contain incorrect catheter sizes, risking treatment delays. Affected kits have specific product codes and were sold in the U.S. Learn how to check and what to do.
ArrowJul 17, 2018 - Lower riskMedical device
Arrow International Inc recalls HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath
Arrow recalls Hands-Off Multi-Lumen Central Venous Catheters with Blue FlexTip due to potential packaging compromise affecting sterility. Affected models include HO-14703 and others listed. Contact Arrow for details.
ArrowJul 10, 2018 - Lower riskMedical device
Arrow International Inc recalls Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502
Arrow recalls pediatric catheter kits with incorrect labeling that may cause confusion in medical use. No injuries reported. Check product code AK-22502 for affected items.
ArrowJul 3, 2018 - Lower riskMedical device
Arrow International Inc recalls Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia.
Arrow recalls Percutaneous Sheath Introducer Kits for 7-7.5 Fr. catheters due to latex content despite label claiming latex-free. Affected kits may cause allergic reactions in sensitive users.
ArrowMay 23, 2018 - Lower riskMedical device
Arrow International Inc recalls Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip
Arrow recalls Peripherally Inserted Midline Catheter Kit with Placement Wire (REF MK-02031-TW) due to pouch label not clearly showing lot number, expiration date, or symbols. This may cause confusion during catheter use.
ArrowMay 17, 2018 - Lower riskMedical device
Arrow International Inc recalls Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to
Arrow recalls Multi-Lumen Central Venous Catheterization Sets with Blue FlexTip Catheter (CS-15853-E) due to potential increased resistance during insertion, which may require medical intervention.
ArrowMay 11, 2018 - Stop using nowMedical device
Arrow International Inc recalls 4Fr. Catheter Clamp with Fastener; Product Code: CC-00004
Arrow recalls 4Fr Catheter Clamps with Fastener (Product Code CC-00004) due to potential unsealed packaging that may compromise sterility. Affected units include specific lot numbers.
ArrowApr 11, 2018 - Stop using nowMedical device
Arrow International Inc recalls (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous
Arrow recalls specific catheter kits due to potential sterility issues. Affected lots may not be sealed properly, risking infection. Consumers should check lot numbers and contact Arrow for details.
ArrowDec 22, 2017 - Lower riskMedical device
Arrow International Inc recalls ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits
Arrow recalls ARROWg+ard Blue PLUS catheters with missing lot numbers and expiration dates. These catheters may not be safe for use due to incomplete labeling.
ArrowDec 21, 2017 - Use cautionMedical device
Arrow International Inc recalls ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
Arrow recalls specific catheter systems with missing safety latches that could cause sharps injuries. Affected units have catalog numbers EDC-00820 or EDC-00820-B with listed lots. Contact Arrow for details.
ArrowDec 15, 2017 - Lower riskMedical device
Arrow International Inc recalls ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide
Arrow recalls some CVC kits for missing lot number and expiration stickers. Check your kit for a sticker with lot number, expiration date, and UDI. Contact Arrow for details.
ArrowNov 27, 2017 - Lower riskMedical device
Arrow International Inc recalls ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central
Arrow recalls Blue PLUS Pressure Injectable Multi-Lumen CVC Kits that lack critical safety checklists for central line insertions. This may lead to errors during medical procedures.
ArrowNov 14, 2017 - Lower riskMedical device
Arrow International Inc recalls Radial Artery Catheterization Kit; Model: AK-04220
Arrow recalls Radial Artery Catheterization Kit model AK-04220 with povidone iodine prep pads that expire after 24 months instead of 36. Affected kits have specific lot numbers and expiration dates.
ArrowOct 26, 2017 - Lower riskMedical device
Arrow International Inc recalls Pneumothorax Kit
Arrow recalls Pneumothorax Kit (AK 01500 CA 0150: Packaging may not be completely sealed. Consumers should check packaging for seal integrity.
ArrowOct 24, 2017 - Lower riskMedical device
Arrow International Inc recalls ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet
Arrow recalls PICC kits with possible 55cm catheter instead of 40cm. This mismatch may cause complications during medical procedures. Affected kits include CDC 34041 VPS Lot# 23F17A0037 and 23F17B0: 150 characters
ArrowOct 17, 2017 - Use cautionMedical device
Arrow International Inc recalls Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety
Arrow recalls pressure injectable multi-lumen catheter kits with possible incorrect springwire guide. Affected kits may have safety risks. Consumers should check product codes and contact Arrow for details.
ArrowOct 17, 2017 - Lower riskMedical device
Arrow International Inc recalls ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central
Arrow recalls PICC catheter kits with incorrect catheter sizes that could delay treatment. Affected kits have specific product codes and batch numbers. Contact Arrow for replacement.
ArrowJul 25, 2017 - Lower riskMedical device
Arrow International Inc recalls Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial
Arrow recalls two radial artery catheter models due to potential loose polypropylene particles that could cause injury during use. Affected lot numbers: 23F16H0859 and 23F16J0547.
ArrowJul 10, 2017 - Use cautionMedical device
Arrow International Inc recalls Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
Arrow recalls EVOLUTION Pressure Injectable PICC catheters with potential hub tab detachment during sheath removal. Affected units may cause injury if catheter dislodges during insertion.
ArrowJun 12, 2017 - Lower riskMedical device
Arrow International Inc recalls ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral
Arrow International recalls PICC kits that might have 5Fr instead of 4Fr peel-away sheaths. This could cause complications during medical procedures. Affected kits have specific lot numbers.
ArrowJun 1, 2017
ARROW INTERNATIONAL Inc. recall questions
How many recalls has ARROW INTERNATIONAL Inc. had?
366 recalls from ARROW INTERNATIONAL Inc. are on record with U.S. safety agencies, from 2017–2024.
What is the most recent ARROW INTERNATIONAL Inc. recall?
ARROW INTERNATIONAL Inc. recalls Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not, dated Jul 26, 2024. Every ARROW INTERNATIONAL Inc. recall is listed on this page, newest first.
Why are ARROW INTERNATIONAL Inc. products recalled?
The most common reasons on record: Product sterility may be compromised due to unsealed packaging. (76); Lidstock states the incorrect expiration date for the product (36); Product lidstock contains the incorrect expiration date for the product (20); These finished good kits may contain the incorrect Springwire Guide (SWG). (12).
What should I do if I have a recalled ARROW INTERNATIONAL Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new ARROW INTERNATIONAL Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.