Skip to content
Get alerts
GovInfoNow
Use caution Medical device recall · FDA · Published July 31, 2023

Datascope Cardiosave Rescue IABP Pumps May Stop Unexpectedly

Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with specific part numbers due to risk of unexpected pump stops during use. Affected units may require replacement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2438-2023Medical deviceDatascope ›
Take action

Contact the company

Recalling firmDatascope Corp.1300 Macarthur Blvd · Mahwah, NJ 07430-2052
✎ GovInfoNow plain-language explainer

Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps with certain part numbers because users may experience unexpected pump stops. This could lead to medical complications if the pump fails during critical cardiac support. Read more at govinfonow.com/recall/57561-datascope-cardiosave-rescue-iabp-pumps-may-stop-unexpectedly.

Source Summary by GovInfoNow · govinfonow.com/recall/57561-datascope-cardiosave-rescue-iabp-pumps-may-stop-unexpectedly · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2438-2023

Cite this page

“Datascope Cardiosave Rescue IABP Pumps May Stop Unexpectedly.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57561-datascope-cardiosave-rescue-iabp-pumps-may-stop-unexpectedly. Based on FDA recall #Z-2438-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2438-2023%22&limit=1).

The FDA announced on July 31, 2023, that Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to autofill failure conditions causing pump stops. The recall affects 9,175 units distributed worldwide.

How to tell if you have it

  • Brand: Datascope
  • Product: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP)
  • Part Numbers: 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
  • Lot Numbers: All Lot Numbers
  • Model 0998-00-0800-75, UDI: 10607567112312
  • Model 0998-00-0800-83, UDI: 10607567108407
  • Model 0998-00-0800-85, UDI: 10607567113449

The hazard

According to the FDA, users were identifying autofill failure conditions on the devices causing pump stops. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Datascope Corp. has 29 other recalls on record since June 17, 2019. Other recent recalls of similar products include Fresenius Kabi Ivenix Infusion Pump Recall (Nov. 3, 2025) and ICU Medical Plum Solo IV Pump Recall (Dec. 15, 2025).

How to tell if you have this one

Check for part numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85. The unique device identifiers (UDIs) listed are 10607567112312, 10607567108407, and 10607567113449.

  • Brand
    Datascope
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • Distribution
    Worldwide - US Nationwide distribution.
Recall numberProduct, codes & lots
Z-2437-2023Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65; All Lot Numbers. Model: 0998-00-0800-31, UDI: 10607567109053; Model: 0998-UC-0800-31, UDI: N/A; Model: 0998-00-0800-32, UDI: 10607567111117; Model: 0998-00-0800-33, UDI: 10607567109008; Model: 0998-UC-0800-33, UDI: N/A; Model: 0998-00-0800-34, UDI: 10607567111940; Model: 0998-00-0800-35, UDI: 10607567109107; Model: 0998-00-0800-45, UDI: 10607567108421; Model: 0998-00-0800-52, UDI: 10607567108438; Model: 0998-UC-0800-52, UDI: N/A; Model: 0998-00-0800-53, UDI: 10607567108391; Model: 0998-UC-0800-53, UDI: N/A; Model: 0998-00-0800-55, UDI: 10607567108414; Model: 0998-UC-0800-55, UDI: N/A; Model: 0998-00-0800-65, UDI: 10607567113432; Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449
Z-2438-2023Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85; All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449
Based on the official FDA remedy

What to do — step by step

  1. Check Pump Part Number

    Identify the part number on your pump to see if it matches the recalled models: 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85.

  2. Contact Manufacturer

    Reach out to Datascope Corp. for guidance on next steps if your pump is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 37 days after the firm started it.

1. Firm started the recall: Jul 31, 202312. FDA classified it Class I: Aug 30, 202323. Published in FDA’s Enforcement Report: Sep 6, 202332023
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2438-2023 (July 31, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2438-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA