Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pumps with faulty Coiled Cord cable that may cause unexpected shutdowns. Affected models include 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. Contact for remedy.
An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit.
Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps that have a Coiled Cord cable which may cause unexpected shutdowns. This could lead to medical complications if the pump fails during use.
The Coiled Cord cable may disconnect from the Cable Assembly backplane, causing the pump to shut down unexpectedly. This could interrupt critical medical support during procedures.
Healthcare professionals using Cardiosave Rescue IABP pumps with the specified model numbers and serial numbers are most at risk. Patients receiving this life-support device could be affected if the pump fails.
Check for model numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85 on the pump. All serial numbers are affected. The part number 0012-00-1801 is also associated with this issue.
Identify if your pump has model numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85.
Reach out to Datascope Corp. for instructions on how to proceed with the recall.
Model numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85 are affected, as well as all serial numbers.
The Coiled Cord cable may disconnect from the Cable Assembly backplane, causing unexpected shutdowns of the pump.
No immediate stop is required, but you should contact Datascope for instructions as the pump may need repair or replacement.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1146-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1146-2023 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.
