Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to risk of unexpected shutdown when running on AC power, potentially causing harm during critical medical use.
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 Hybrid Intra-Aortic Balloon Pumps (IABP) models because they can unexpectedly shut down when running on AC power if only one battery is installed and the battery is removed while charging. This hazard could cause serious harm during critical medical procedures.
The pump can shut down unexpectedly when running on AC power if only one battery is installed and the battery is removed while charging. This occurs during a very specific set of conditions that could interrupt life-saving support during critical medical procedures.
Patients using these pumps for critical cardiac support are most at risk. Healthcare providers who use the device in hospitals or clinics may also be affected.
Check for model numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, or 0998-00-0800-65. All lots of these models are affected.
Ensure the pump has two batteries installed and the battery is not removed while charging.
Confirm the model number matches the recalled list: 0998-00-0800-31 to 0998-00-0800-65.
The Cardiosave IABP may unexpectedly shut down when running on AC power if only one battery is installed and the battery is removed while charging, which could cause serious harm during critical medical procedures.
No, but you should check the battery installation and model number to ensure safety. The recall does not require immediate discontinuation.
Model numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, and 0998-00-0800-65.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2615-2021 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2615-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
