Datascope recalls Cardiosave Intra-Aortic Balloon Pump Safety Disk Model 0202-00-0140 with serial numbers listed. The Safety Disk may cause slightly reduced inflation during therapy, potentially affecting patient augmentation.
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 a specific Safety Disk model for Cardiosave Intra-Aortic Balloon Pumps. This recall is due to a potential issue that could slightly reduce inflation during therapy, which might affect how well the device supports the patient.
The Safety Disk may not meet performance requirements, leading to slightly reduced inflation during therapy. This could mean the device provides less augmentation to the patient than intended, but it's not a critical failure.
Patients using Cardiosave Intra-Aortic Balloon Pump systems with the recalled Safety Disk model are most at risk. This recall affects medical devices used in critical care settings.
Check your Cardiosave Intra-Aortic Balloon Pump for the Safety Disk model number 0202-00-0140. The recall includes specific serial numbers listed in the official notice.
Look for the serial number on your device to confirm if it's in the list of affected units provided in the recall notice.
The recall indicates a potential issue that could slightly reduce inflation during therapy, but it's not described as causing serious injury or immediate danger.
The recall does not specify a remedy, so you should check the serial number against the list provided to see if your device is affected.
Check your device's serial number against the list of affected serial numbers provided in the official 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-1278-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1278-2023 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.
