Datascope recalls Cardiosave IABP pumps with specific part numbers due to potential fiber optic sensor failure during use. Affected units may have safety risks during medical procedures.
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 specific Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) models because they can fail when inserting the fiber optic connector. This could lead to improper function during medical procedures, which is serious for patients needing this life-support device.
The IABP pumps may fail when the fiber optic connector is inserted, potentially causing improper function during medical procedures. This could lead to inadequate blood flow support for patients in critical condition.
Healthcare professionals using the Cardiosave IABP pumps for critical care patients are most at risk. Patients receiving this life-support treatment could be affected if the pump malfunctions.
Check for part numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85 on the pump. These models were sold with specific unique device identifiers (UDIs) listed in the recall notice.
Identify the pump model number by checking the label on the device.
Reach out to Datascope Corp. for guidance on whether your pump is affected and next steps.
The IABP pumps may fail when inserting the fiber optic connector, potentially causing improper function during medical procedures.
Part numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85.
The recall does not require immediate discontinuation; healthcare professionals should check if their pump is affected and contact Datascope 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-2487-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-2487-2023 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.
