Datascope recalls Cardiosave Rescue models 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85 due to potential unexpected shutdowns that could interrupt therapy and threaten patient hemodynamic stability.
An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy which may threaten the hemodynamic stability of the supported patient as the user is left unaware to the status of the Cardiosave IABP.
Datascope is recalling specific Cardiosave Rescue models because an unexpected shutdown might occur, interrupting therapy and risking the patient's hemodynamic stability without the user knowing the device's status.
The device may shut down unexpectedly due to communication loss between its processor and video generator components. This interruption could disrupt life-support therapy, potentially causing instability in the patient's blood pressure and heart function without the user being aware.
Patients using the Cardiosave Rescue device are most at risk, particularly those with critical cardiac conditions requiring continuous hemodynamic support.
Check for model numbers 0998-00-0800-75, 0998-00-0800-83, or 0999-00-0800-85 on the device. The recall includes all units with the listed serial numbers provided in the official notice.
Ensure the device is functioning properly by observing for unexpected shutdowns or therapy interruptions.
Models 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85.
The recall does not specify a fix or remedy; users should monitor for unexpected shutdowns.
Check the model number on your device; affected models are 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1148-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1148-2023 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.
