Datascope recalls Cardiosave Hybrid IABP devices due to potential hemodynamic instability and clinical data transmission failure. Affected units include 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 Hybrid Intra-Aortic Balloon Pumps (IABP) because software issues could cause hemodynamic instability or failure to transmit clinical data. This recall affects medical devices used in critical care settings.
The devices use an electromechanical system to inflate and deflate intra-aortic balloons. Software problems could lead to hemodynamic instability (abnormal blood flow) or failure to send critical clinical data to healthcare providers.
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 is not addressed.
Check for product numbers starting with 0998-00-0800-31 to 0998-00-0800-65 or UDI codes listed in the recall notice. All lots are affected.
Verify your Cardiosave Hybrid IABP device model against the listed product numbers or UDI codes to confirm if it is affected.
Reach out to Datascope Corp. for guidance on software corrections or alternative solutions.
No, only specific product numbers and UDI codes listed in the recall notice are affected.
Contact Datascope Corp. for instructions on software corrections or other remedies.
The recall addresses potential hemodynamic instability and clinical data transmission failure, but no immediate patient harm has been reported.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-3134-2024 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-3134-2024 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.
