Datascope recalls Cardiosave Rescue Intra-Aortic Balloon Pump models 0998-00-0800-75, 83, 85 due to risk of unexpected shutdown when running on AC power with one battery installed and being charged.
The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
Datascope is recalling specific Cardiosave Rescue Intra-Aortic Balloon Pump models because they can unexpectedly shut down while running on AC power. This could be dangerous for patients using the device during critical medical procedures.
The device may shut down unexpectedly when running on AC power if only one battery is installed and the battery is physically removed while charging. This specific condition can occur during medical procedures, potentially causing harm to patients.
Patients using the Cardiosave IABP for critical medical procedures are most at risk. Healthcare providers who use these pumps in hospitals or clinics may also be affected.
Check for model numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85 on the device. These pumps were sold in the U.S. and are used in medical settings.
Identify the model number on the device to confirm if it is one of the recalled models: 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85.
Contact your healthcare provider or hospital to discuss the recall and potential next steps for the device.
The Cardiosave IABP may unexpectedly shut down when running on AC power if only one battery is installed and the battery is physically removed while charging.
Check the model number to see if it is one of the recalled models. Contact your healthcare provider for guidance.
The recall record does not mention a specific fix or remedy.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2616-2021 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2616-2021 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.
