Use cautionMedical device recall · FDA · Published June 5, 2023
Datascope Cardiosave Hybrid IABP Recalled: Risk of Unexpected Shutdown
Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential unexpected shutdowns from capacitor failures, which could interrupt life-saving therapy.
An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
Datascope is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps with model numbers 0998-00-0800-31 to 0998-00-0800-65 and 0998-UC-0800-31 to 0998-UC-0800-53. This recall is because faulty tantalum capacitors in the pump's power and solenoid boards may cause unexpected shutdowns, interrupting critical therapy for patients with heart conditions. Read more at govinfonow.com/recall/57901-datascope-cardiosave-hybrid-iabp-recalled-risk-of-unexpected-shutdown.
“Datascope Cardiosave Hybrid IABP Recalled: Risk of Unexpected Shutdown.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57901-datascope-cardiosave-hybrid-iabp-recalled-risk-of-unexpected-shutdown. Based on FDA recall #Z-2151-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2151-2023%22&limit=1).
The FDA announced on June 5, 2023, that Datascope Corp. is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps due to a hazard of unexpected shutdowns. This recall affects units distributed worldwide.
According to the FDA, an unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
Context
GovInfoNow's records show Datascope Corp. has 29 other recalls on record since June 17, 2019. Other recent recalls include a February 6, 2026 recall for a Battery Charging Station due to protruding screws and a January 23, 2026 software update for the CS300 IABP. Similar product recalls include a May 13, 2026 Thoratec HeartMate 3 LVAS Kits recall for battery failures, a May 6, 2026 Fresenius Kabi Ivenix Infusion System software recall, and a November 3, 2025 Fresenius Kabi Ivenix Infusion Pump recall.
How to tell if you have this one
Check your pump's model number on the device or its packaging. The affected models include 0998-00-0800-31 through 0998-00-0800-65 and 0998-UC-0800-31 through 0998-UC-0800-53. Note that some models are not distributed in the U.S.
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 Distribution- US (Nationwide) and OUS (foreign) countries of: ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, AZERBAIJAN , BAHRAIN, BANGLADESH, BARBADOS, BELARUS, BELGIUM, BOSNIA and HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, C¿te d'Ivoire, CROATIA, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GHANA, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOSOVO, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, TURKMENISTAN, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM, YEMEN, ZAMBIA
Recall number
Product, codes & lots
Z-2151-2023
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* *Not US distribution; All Unit Serial Numbers Model UDI 0998-00-0800-31 10607567109053 0998-00-0800-32 10607567111117 0998-00-0800-33 10607567109008 0998-00-0800-34 10607567111940 0998-00-0800-35 10607567109107 0998-00-0800-45 10607567108421 0998-00-0800-52 10607567108438 0998-00-0800-53 10607567108391 0998-00-0800-55 10607567108414 0998-00-0800-65 10607567113432
Z-2152-2023
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85; All Unit Serial Numbers Model UDI 0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449
Based on the official FDA remedy
What to do — step by step
Check Model Number
Look for the model number on the pump or its packaging to confirm if it is affected.
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.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution- US (Nationwide) and OUS (foreign) countries of: ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, AZERBAIJAN , BAHRAIN, BANGLADESH, BARBADOS, BELARUS, BELGIUM, BOSNIA and HERZEGOVINA, BRAZIL,…” 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 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2151-2023 (June 5, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2151-2023 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.