Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with specific part numbers due to improper console insertion preventing battery charging. Affected units may not charge if the console isn't fully inserted into the hospital cart.
Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.
Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps with part numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85 because users may not be charging the device properly. This could lead to the pump not functioning correctly during medical emergencies.
The pump's battery may not charge if the console is not fully inserted into the hospital cart. This can cause the device to malfunction during critical medical procedures, potentially affecting patient care.
Healthcare professionals using the Cardiosave pumps in hospitals are most at risk. Patients receiving these pumps during critical medical situations could be affected if the device fails to charge.
Check for part numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85 on the pump. These units were sold with specific unique device identifiers (UDIs) listed in the recall notice.
Ensure the Cardiosave console is fully inserted into the hospital cart before use to prevent battery charging issues.
The recall is due to users not being aware that the console must be fully inserted into the hospital cart for the battery to charge properly.
Check for part numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85 on the pump, as these specific units were affected.
The recall does not require returning the pump; users should ensure the console is fully inserted into the cart for proper charging.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2432-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2432-2023 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.
