Datascope recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps with specific model numbers due to potential safety disk issues that could reduce inflation during therapy. Affected units include model numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85.
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
Datascope is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps with model numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. The recall is due to a potential issue with the Safety Disk that could slightly reduce inflation during therapy, which might affect patient treatment.
The Safety Disk in the pump may not meet performance requirements, leading to slightly reduced inflation during therapy. This could result in less effective augmentation of blood flow to the patient, potentially affecting treatment outcomes.
Patients using Cardiosave Hybrid Intra-Aortic Balloon Pumps with the specified model numbers are affected. Medical professionals who use these devices for cardiac support are most at risk.
Check for model numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85 on the pump. Serial numbers CA237026J3 and CH231276C6 are also associated with these models.
Look for model numbers 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85 on the pump.
The Safety Disk may not meet performance requirements, which could lead to slightly reduced inflation during therapy or less effective augmentation of blood flow to the patient.
Model numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85 are affected.
The recall does not specify a remedy, so no action is required beyond checking if your pump is affected.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1277-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1277-2023 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.
