Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential battery charging failures that could interrupt therapy. Affected units may require replacement to prevent therapy interruptions.
IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to interruption of therapy.
Datascope is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps with model numbers 0998-00-0800-31 through 0998-00-0800-65 and 0998-UC-0800-31 through 0998-UC-0800-53. The pumps may lose battery charge in one or both bay slots, risking therapy interruption if the device disconnects from AC power.
The device may lose the ability to charge batteries in one or both bay slots. If batteries fail to charge and the device disconnects from AC power, therapy could be interrupted. Low battery alarms may alert users before this happens.
Patients using the Cardiosave Hybrid Intra-Aortic Balloon Pump for cardiac support are most at risk. The recall applies to specific model numbers sold in the U.S. and Canada.
Check for model numbers 0998-00-0800-31 through 0998-00-0800-65 or 0998-UC-0800-31 through 0998-UC-0800-53 on the pump. Units sold in the U.S. and Canada are affected.
Look for low battery alarms or disconnections from AC power to determine if the device is functioning properly.
Reach out to Datascope Corp. for guidance on whether the device needs replacement or repair.
The Cardiosave Hybrid Intra-Aortic Balloon Pump may lose the ability to charge batteries in one or both bay slots, which could interrupt therapy if the device disconnects from AC power.
Model numbers 0998-00-0800-31 through 0998-00-0800-65 and 0998-UC-0800-31 through 0998-UC-0800-53.
No, but if you experience low battery alarms or disconnections from AC power, stop using the pump and contact Datascope Corp. for assistance.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2149-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2149-2023 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.
