Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with faulty Coiled Cord cable that may cause unexpected shutdowns. Affected models include specific serial numbers and UDI-DI codes.
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 Hybrid 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 can fail to connect properly with the Cable Assembly backplane, causing the pump to shut down unexpectedly. This interruption in communication between the display head and base unit could lead to medical complications if the pump fails during critical cardiac support.
Healthcare professionals using Cardiosave Hybrid IABP pumps with the specified model numbers and serial numbers are most at risk. Patients relying on these pumps for critical cardiac support may be affected.
Check for model numbers 0998-00-0800-31 through 0998-00-0800-65, or serial numbers listed in the recall notice. The Coiled Cord cable is part number 0012-00-1801.
Identify if your pump has model numbers 0998-00-0800-31 through 0998-00-0800-65 or the listed serial numbers.
Reach out to Datascope Corp. for further assistance with the recall.
The Coiled Cord cable (part number 0012-00-1801) may fail to connect properly with the Cable Assembly backplane.
Check for model numbers 0998-00-0800-31 through 0998-00-0800-65 or the listed serial numbers in the recall notice.
Contact Datascope Corp. for further assistance with the recall.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1145-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1145-2023 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.
