Atrium Medical Corporation recalls
Every recall we track for Atrium Medical Corporation — 91 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Atrium Medical Corporation dropped to zero in 2025 (0, down from 69 in 2024).
All FDA recall records for Atrium Medical Corporation 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 | 0 | 0 | 0 | 1 | 1 |
| 2018 | 0 | 1 | 0 | 0 | 1 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 1 | 1 | 3 |
| 2022 | 0 | 2 | 2 | 0 | 4 |
| 2023 | 0 | 6 | 4 | 0 | 10 |
| 2024 | 0 | 12 | 34 | 23 | 69 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 3 | 0 | 3 |
What to do if you have a recalled Atrium Medical Corporation 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 Atrium Medical Corporation recalls
17 shown- Lower riskMedical device
Atrium Medical Corporation recalls Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3.
Getinge recalls specific PVC thoracic catheters due to bacterial endotoxin testing failures in one lot. Affected units have model numbers 8016-8036 with specific lot numbers. Consumers should contact the manufacturer for details.
GetingeAug 7, 2026 - Lower riskMedical device
Atrium Medical Corporation recalls iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Atrium Medical recalls iCast Covered Stent Model 42616 due to a UDI label error. Affected units have specific serial numbers and lot numbers. Contact for replacement.
Atrium MedicalSep 9, 2024 - Use cautionMedical device
Atrium Medical Corporation recalls ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Atrium Medical recalls ADVANTA VXT vascular grafts with reported Slider GDS Swivel Rod separation. Affected units have specific model codes; contact for remedy.
Atrium MedicalMay 3, 2024 - Lower riskMedical device
Atrium Medical Corporation recalls Atrium Oasis Drain Single W / AC, Part No. 3600-100
Atrium Medical recalls specific Oasis Drain Single W/AC models with inaccurate expiration dates, risking patient safety after November 17, 2025.
Atrium MedicalNov 1, 2023 - Lower riskMedical device
Atrium Medical Corporation recalls Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Atrium Medical recalls a specific thoracic catheter model due to an inaccurate expiration date from sterilization issues. Affected units have a labeled expiry date of February 2023 but may expire earlier.
Atrium MedicalSep 29, 2023 - Use cautionMedical device
Atrium Medical Corporation recalls Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of
Atrium Medical recalls V12 covered stents for potential balloon-catheter weld failure during renal artery procedures. Affected units include specific sizes and lot numbers. Contact for remedy.
Atrium MedicalSep 21, 2023 - Use cautionMedical device
Atrium Medical Corporation recalls Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
Atrium Medical recalls Express Dry Seal Chest Drains with insufficient setup instructions for catheter connections, potentially causing improper patient tube connections. Affected models include 4000-100N DRAIN and 4050-100N DRAIN, manufactured from July 21, 2020 onward.
Atrium MedicalSep 18, 2023 - Lower riskMedical device
Atrium Medical Corporation recalls Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Atrium Medical recalls Oasis Dry Suction Water Seal Chest Drains with part number 3650-100 due to improper sterilization process by a third party. Affected units include specific lots; contact for remedy.
Atrium MedicalSep 5, 2023 - Use cautionMedical device
Atrium Medical Corporation recalls Express Mini 500 Dry Seal Chest Drain, Part Number 16400
Atrium Medical recalls Express Mini 500 Dry Seal Chest Drains (Part 16400) due to insufficient safety instructions for home use, risking injury if misused outside healthcare settings.
Atrium MedicalMar 1, 2023 - Lower riskMedical device
Atrium Medical Corporation recalls Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
Atr:ium Medical recalls Ocean Wet Suction Water Seal Chest Drains due to potential temperature excursions in 2021. No patient harms reported.
Atrium MedicalOct 18, 2022 - Lower riskMedical device
Atrium Medical Corporation recalls Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest
Atrium Medical recalls 28French thoracic catheters due to sterile pouch expiring 5 days before case label. This mismatch risks infection from using expired sterile materials.
Atrium MedicalApr 21, 2022 - Use cautionMedical device
Atrium Medical Corporation recalls Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326
Atrium Medical recalls specific stent models due to increased risk of balloon or catheter hub separation during delivery, potentially causing procedural delays, additional anesthesia, and kidney damage. Affected products include 85320-85398 series.
Atrium MedicalMar 3, 2022 - Use cautionMedical device
Atrium Medical Corporation recalls The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection
Atrium Medical recalls Ocean Water Seal Chest Drain devices due to unclear setup instructions that may delay treatment and cause patient harm. Affected units have specific lot codes.
Atrium MedicalOct 22, 2021 - UnratedMedical device
Atrium Medical Corporation recalls Atrium Pneumostat Chest Drain Valve, Part Number 16100
Atrium Medical recalls specific chest drain valve models due to involvement in a preterm infant's death. Learn which units are affected and safety steps.
Atrium MedicalAug 26, 2021 - Lower riskMedical device
Atrium Medical Corporation recalls Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial
Atrium Medical recalls specific ADVANTA VXT vascular grafts that may have a mismatched graft without the radial support ring, potentially causing complications during arterial procedures.
Atrium MedicalAug 25, 2021 - Use cautionMedical device
Atrium Medical Corporation recalls Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
Atrium Medical recalls specific thoracic catheters due to seal defects in sterile pouches that could cause contamination. Affected units may pose serious infection risks if not properly sealed.
Atrium MedicalOct 12, 2018 - UnratedMedical device
Atrium Medical Corporation recalls ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia
Atrium Medical recalls ProLite Mesh product code 1010306-06 with lot 412298 due to incorrect packaging configuration that may lead to improper use in hernia repairs.
Atrium MedicalNov 22, 2017
Atrium Medical Corporation recall questions
How many recalls has Atrium Medical Corporation had?
91 recalls from Atrium Medical Corporation are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Atrium Medical Corporation recall?
Atrium Medical Corporation recalls Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3., dated Aug 7, 2026. Every Atrium Medical Corporation recall is listed on this page, newest first.
What should I do if I have a recalled Atrium Medical Corporation 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 Atrium Medical Corporation 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.