Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific part numbers due to overheating alarms causing system shutdowns. Affected units may lose pumping function and enter standby mode.
Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
Datascope is recalling certain Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) models because users reported overheating alarms that can cause the system to stop working. This poses a risk to patients using the device as it may lead to loss of critical blood flow support.
The pumps can trigger overheating alarms that cause the system to stop pumping blood or enter standby mode. This means the device may fail to provide necessary circulatory support during critical medical situations.
Patients using the recalled Cardiosave Hybrid IABP pumps for medical treatment are most at risk. Healthcare providers who have these devices in their inventory should also check if they have affected units.
Check for part numbers 0998-00-0800-31 through 0998-00-0800-85 and 0998-UC-0800-31 through 0998-UC-0800-65. The device may also have a unique identification number (UDI) listed in the recall details.
Look for overheating alarms or the system entering standby mode, which may indicate the pump is malfunctioning.
Reach out to Datascope Corp. for assistance with the recall process or to confirm if your specific model is affected.
Users reported overheating alarms that can cause the system to stop pumping blood or enter standby mode, potentially leading to loss of critical circulatory support.
Part numbers 0998-00-0800-31 through 0998-00-0800-85 and 0998-UC-0800-31 through 0998-UC-0800-65 are affected.
The recall does not require immediate discontinuation; however, if you experience overheating alarms, stop using the pump and contact Datascope Corp. for guidance.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2433-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2433-2023 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.
