Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with specific model numbers due to risk of unexpected shutdown from blood entering the device during therapy with a compromised catheter.
The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps with model numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. The device may shut down unexpectedly if blood enters during therapy with a compromised catheter, which could lead to medical complications.
The Cardiosave IABP can shut down unexpectedly when blood enters the device during therapy if the intra-aortic balloon catheter is compromised. This interruption in support could cause medical complications for patients needing continuous cardiac assistance.
Healthcare professionals using the Cardiosave IABP for cardiac support are most at risk. Patients receiving this device during critical care situations may also be affected.
Check for model numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85 on the device. The product may also be identified by serial numbers or part numbers like D998.
Verify the model number on the device to confirm if it is one of the recalled numbers: 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85.
Reach out to Datascope Corp. for guidance on next steps if the device is recalled.
Model numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85 are affected.
The Cardiosave IABP may shut down unexpectedly due to blood entering the device when therapy is provided with a compromised intra-aortic balloon catheter.
Check for model numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85 on the device. The product may also be identified by serial numbers or part numbers like D998.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-0886-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-0886-2023 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.
