Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) due to risk of hemodynamic instability and clinical data transmission failure. Affected units have specific product numbers and UDI codes.
Firm has developed a software correction (Revision D.00) 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 (IABPs) because software issues could cause hemodynamic instability or failure to transmit clinical data. This may affect patients using the device for critical care.
The device's software may cause hemodynamic instability (abnormal blood flow) or fail to transmit critical clinical data. This could lead to complications during medical treatment if the device malfunctions.
Healthcare professionals using Cardiosave Rescue IABPs for critical care patients are most at risk. Patients with specific product numbers or UDI codes may 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.
Identify your product number and UDI code to confirm if it's affected.
Yes, patients using Cardiosave Rescue IABPs with specific product numbers or UDI codes may be affected.
Check your product number and UDI code to see if it's in the recall list. Contact Datascope for further instructions.
Yes, Datascope has developed a software correction (Revision D.00) to address the issue, but it's only available outside the US.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-3135-2024 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-3135-2024 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.
