Lower risk Medical device recall · FDA · Published September 21, 2021

Datascope Cardiosave Li-Ion Battery Pack Recall: Battery Fails Runtime Test

Datascope recalls Cardiosave Li-Ion Battery Packs (Part No. 0146-00-0097) used in Cardiosave Hybrid and Rescue IABP models due to failing runtime tests. Affected units have specific model and serial numbers.

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

🇺🇸 FDA recall #Z-0091-2022Medical device Datascope ›

Lower-risk recall

A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.

Take action

Contact the company

Recalling firmDatascope Corp.1300 Macarthur Blvd · Mahwah, NJ 07430-2052

✎ GovInfoNow plain-language explainer

Datascope is recalling certain Cardiosave Li-Ion Battery Packs that failed to meet minimum runtime requirements during testing. These nonconforming batteries were released to customers without proper quality checks, potentially causing equipment failure during critical medical procedures. Read more at govinfonow.com/recall/61787-datascope-cardiosave-li-ion-battery-pack-recall-battery-fails-runtime.

Source Summary by GovInfoNow · govinfonow.com/recall/61787-datascope-cardiosave-li-ion-battery-pack-recall-battery-fails-runtime · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0091-2022

Cite this page

“Datascope Cardiosave Li-Ion Battery Pack Recall: Battery Fails Runtime Test.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61787-datascope-cardiosave-li-ion-battery-pack-recall-battery-fails-runtime. Based on FDA recall #Z-0091-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0091-2022%22&limit=1).

The FDA announced on 2021-09-21 that Datascope Corp. is recalling Cardiosave Li-Ion Battery Packs because they failed to meet minimum runtime requirements during testing. The agency classified the recall as Class I.

How to tell if you have it

Brand: Datascope
Product: Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097
Compatible Pumps: Cardiosave Hybrid (Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 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-UC-0800-55) and Cardiosave Rescue (Model Number 0998-00-0800-83)
Distribution: Worldwide, including US nationwide, Australia, Brazil, Bahrain, Belgium, Canada, China, Czech Republic, Egypt, France, Germany, India, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, Pakistan, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, UK, United Arab Emirates, Philippines, and Russia

The hazard

The Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers.

Context

GovInfoNow's records show Datascope Corp. has 29 other recalls on record since 2019-06-17. Other recent recalls of similar products include HeartMate 11V Backup Battery Recall (2026-05-13), Fresenius Kabi Ivenix Infusion System Software Recall (2026-05-06), and Thoratec HeartMate 3 LVAS Kits Recall (2026-05-13).

How to tell if you have this one

Check if your Cardiosave Hybrid or Rescue pump has model numbers listed in the recall (e.g., 0998-00-0800-31) or battery serial numbers from the provided list. The battery part number is 0146-00-0097.

Brand
Datascope
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Battery Serial Number
Look for battery serial numbers on the battery pack, which should match the list provided in the recall notice.
Contact Manufacturer
Contact Datascope Corp. to confirm if your battery is affected and get instructions for replacement or return.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution. US nationwide, Australia, Brazil, Bahrain, Belgium, Canada, China, Czech Republic, Egypt, France, Germany, India, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, Pakistan, Saudi Arabia, Singapore, South Africa,…” 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 36 days after the firm started it.

Sep 21, 2021Firm started the recall
Oct 20, 2021FDA classified it Class I
Oct 27, 2021Published in FDA’s Enforcement Report

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

Similar recalls

Latest medical device recalls

Keep exploring

More Datascope recalls

Link to this recall

<a href="https://govinfonow.com/recall/61787-datascope-cardiosave-li-ion-battery-pack-recall-battery-fails-runtime">Datascope Cardiosave Li-Ion Battery Pack Recall: Battery Fails Runtime Test (GovInfoNow)</a>

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-0091-2022 (September 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0091-2022 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.