Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific part numbers due to battery charging issues when 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 certain Cardiosave Hybrid Intra-Aortic Balloon Pumps because users may not be charging properly if the console isn't fully inserted into the hospital cart. This could lead to the device not functioning correctly during medical use.
The device requires the console to be completely inserted into the hospital cart for proper battery charging. If the console is not fully inserted, the battery will not charge, potentially causing the pump to malfunction during critical medical procedures.
Healthcare professionals using the Cardiosave pumps in hospitals are most at risk, particularly those who may not have noticed the console isn't fully inserted into the cart.
Check for part numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, and other listed models. The device was sold with specific lot numbers and unique identifiers (UDIs) as detailed in the recall notice.
Ensure the Cardiosave console is fully inserted into the hospital cart before use to allow proper battery charging.
The pump may not be charging if the console is not fully inserted into the hospital cart. Check the console's position in the cart.
Part numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, and other specific models listed in the recall notice.
The recall does not require returning the pump; users should check if 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-2431-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2431-2023 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.
