Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) due to software issues that may cause 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 Rescue Intra-Aortic Balloon Pumps (IABP) because software problems could cause unstable blood flow or failure to send critical health data. This is serious for patients using the device for heart support.
The software issue can cause unstable blood flow (hemodynamic instability) and prevent the device from sending critical health data to medical staff. This could lead to complications if the device fails during use.
Patients using Cardiosave Rescue IABP devices for heart support are most at risk. Healthcare providers who have the device may also be affected.
Check for product numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85. Also look for UDI codes 10607567112312, 10607567108407, or 10607567113449 on the device packaging.
Verify if your Cardiosave Rescue IABP has the product numbers or UDI codes listed in the recall notice.
The recall applies to specific product numbers and UDI codes. Check the product numbers or UDI codes on your device to see if it's affected.
The recall notice does not specify a remedy for this issue. You should check with your healthcare provider for guidance on next steps.
Look for product numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85, or UDI codes 10607567112312, 10607567108407, or 10607567113449 on the device packaging.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-3137-2024 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-3137-2024 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.
