Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) model 0998-00-0800-53 due to battery short-run times and unanticipated stoppages from improper maintenance. Affected units may require battery care to prevent sudden stops during cardiovascular use.
Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and design updates will be handled in a subsequent recall.
Datascope is recalling a specific model of intra-aortic balloon pump used in heart care because battery issues could cause sudden stops during medical procedures. This affects patients and healthcare providers using the device without proper battery maintenance.
The device may stop unexpectedly during use because users aren't maintaining the battery properly. This could lead to sudden interruptions in critical heart support, especially during medical procedures where continuous function is essential.
Healthcare providers and patients using the Cardiosave Hybrid IABP device with the specific serial number 0998-00-0800-53 are affected. Those who rely on the device for cardiovascular support are most at risk due to potential unplanned stops.
Check for the serial number 0998-00-0800-53 on the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) device. This model is used for cardiovascular procedures and was sold with the specified serial number.
Ensure the battery is maintained according to manufacturer guidelines to prevent unplanned stops.
The device may be safe if battery maintenance is performed correctly, but improper handling could cause unplanned stops during use.
The official recall does not specify a return or replacement process; users should check battery maintenance procedures.
Look for the serial number 0998-00-0800-53 on the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) device.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1939-2019 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1939-2019 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.
