Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific part numbers due to potential failure in the IAB Fiber Optic Sensor input during connector insertion.
Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
Datascope is recalling certain Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) models because the IAB Fiber Optic Sensor input may fail when inserting the Intra-Aortic Balloon Fiber Optic connector. This could lead to improper function of the pump, which is critical for medical use.
The IAB Fiber Optic Sensor input can fail when inserting the Intra-Aortic Balloon Fiber Optic connector. This failure may cause the pump to malfunction, potentially leading to inadequate cardiac support for patients who depend on it.
Healthcare professionals using the recalled Cardiosave Hybrid IABP models are most at risk. Patients relying on these pumps for critical cardiac support may need immediate attention if the device fails.
Check for part numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, or other listed models. The device may have a unique device identifier (UDI) listed in the recall details.
Identify your Cardiosave Hybrid IABP model by checking the part number or unique device identifier (UDI) on the device.
Reach out to Datascope Corp. for further instructions on how to address the issue with your specific model.
The affected part numbers include 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, and other specific models listed in the recall notice.
The recall notice does not specify a fix; users are advised to contact Datascope Corp. for further instructions.
Check the part number or unique device identifier (UDI) on your pump against the list of affected models provided in the recall notice.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-2486-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2486-2023 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.
