Datascope recalls Cardiosave Rescue IntraAortic Balloon Pumps with specific model numbers due to risk of fluid entering the device, potentially causing system shutdown and unsafe hemodynamic instability.
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
Datascope is recalling Cardiosave Rescue IntraAortic Balloon Pumps with model numbers 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, and others. Fluid entering the device could cause system shutdown, leading to unsafe blood pressure levels for patients.
Fluid entering the device can short electronic components, causing the pump to shut down unexpectedly. This may lead to unsafe blood pressure levels in patients who rely on the pump for critical cardiac support.
Healthcare professionals using the Cardiosave Rescue IntraAortic Balloon Pump for cardiac emergencies are most at risk. Patients receiving this device during critical care situations could experience unstable blood pressure if the pump fails.
Check the model numbers on the pump: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, or 0998-UC-0800-85. The pump may also have serial numbers listed in the recall notice.
Look for model numbers on the pump: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, or 0998-UC-0800-85.
Model numbers 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, and 0998-UC-0800-85 are affected.
Fluid entering the device can short electronic components, potentially causing system shutdown and unsafe hemodynamic instability.
Check the model numbers to see if your pump is affected. If it is, contact Datascope for further instructions.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-0337-2022 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-0337-2022 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.
