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.
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.
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.
The battery packs failed to meet minimum runtime requirements per Getinge internal specifications. This means they could run out of power during critical medical procedures, potentially causing equipment failure when needed most.
Medical professionals using Cardiosave Hybrid or Rescue Intra-Aortic Balloon Pumps with the listed model numbers and battery serial numbers are affected. Patients using these pumps during critical procedures may be at risk if the battery fails unexpectedly.
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.
Look for battery serial numbers on the battery pack, which should match the list provided in the recall notice.
Contact Datascope Corp. to confirm if your battery is affected and get instructions for replacement or return.
The battery failed to meet minimum runtime requirements during internal testing, so it was inadvertently released to customers without proper quality checks.
Cardiosave Hybrid pumps with model numbers 0998-00-0800-31 through 0998-00-0800-65 and Cardiosave Rescue with model number 0998-00-0800-83.
No, but you should check if your battery is on the list and contact Datascope to get replacement instructions.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-0091-2022 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-0091-2022 from Datascope. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
