Datascope recalls Cardiosave Hybrid IABP devices due to potential hemodynamic instability and clinical data transmission failure. Affected units have specific product numbers and UDI codes.
Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
Datascope is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) because software issues could cause hemodynamic instability and failure to transmit clinical data. This affects medical devices used in critical care settings.
The software correction (Revision D.01) is needed to prevent hemodynamic instability and ensure clinical data transmission works properly. Without this update, the device could fail to inflate or deflate the balloon correctly, potentially causing dangerous blood pressure fluctuations.
Healthcare professionals using Cardiosave Hybrid IABP devices in hospitals or critical care facilities are most at risk. Patients receiving these devices may experience complications if the software issue remains unaddressed.
Check for product numbers starting with 0998-00-0800 or 0998-UC-0800, and UDI codes listed in the record. All lots are affected, so no specific lot numbers are safe.
Verify your Cardiosave Hybrid IABP has software revision D.01 or higher. Older versions may have the issue.
Reach out to Datascope Corp. to get the software correction (Revision D.01) for your device.
Yes, all Cardiosave Hybrid IABP devices with product numbers listed in the recall are affected.
No, but you should check for the software update to prevent potential hemodynamic instability.
Affected devices have UDI codes: 10607567109053, 10607567111117, 10607567109008, 10607567111940, 10607567109107, 10607567114187, 10607567108421, 10607567108438, 10607567108391, 10607567108414, 10607567113432.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-3136-2024 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-3136-2024 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.
