Datascope recalls Cardiosave Hybrid models 0998-00-0800-31 to 0998-00-0800-65 due to potential IABP shutdown causing therapy interruption and hemodynamic instability.
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 Hybrid models because a communication failure between internal components could cause sudden shutdown of the device, potentially interrupting life-support therapy and risking patient hemodynamic stability without the user being aware.
The device may unexpectedly shut down because of communication loss between the Executive Processor PCBA and Video Generator PCBA. This interruption could stop life-support therapy, causing the patient's hemodynamic stability to drop without the user knowing the device has stopped working.
Patients using the Cardiosave Hybrid for hemodynamic support are affected. Those with the recalled model numbers are most at risk due to potential therapy interruption.
Check for model numbers 0998-00-0800-31 through 0998-00-0800-65 on the device. The recall includes specific serial numbers listed in the official notice.
Verify if the device is functioning properly by observing for unexpected shutdowns or therapy interruptions.
Reach out to Datascope Corp. for further guidance on device status and potential remedies.
The recall is due to a potential communication failure between the Executive Processor PCBA and Video Generator PCBA that could cause the device to unexpectedly shut down, interrupting life-support therapy.
Models 0998-00-0800-31 through 0998-00-0800-65, including specific serial numbers listed in the official notice.
The recall record does not specify a remedy, so no immediate fix is provided. Users should contact Datascope Corp. for further instructions.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1147-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1147-2023 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.
