Datascope recalls Cardiosave IABP Pneumatic Interface Module Model 0997-00-1178 due to potential safety disk failure causing reduced inflation during therapy. Affected units have specific serial numbers listed.
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 model of Cardiosave Intra-Aortic Balloon Pump pneumatic interface module because a safety disk might not work properly, which could lead to less effective inflation during medical treatment. This is a serious issue for patients using this device for heart support.
The safety disk in the module may not meet performance standards, which could cause the balloon to inflate less effectively during therapy. This might reduce the support the device provides to the heart, potentially affecting treatment outcomes.
Patients using the Cardiosave IABP system with the recalled pneumatic interface module are most at risk. Healthcare providers who use this device for critical care situations should also check if their equipment is affected.
Check for the model number 0997-00-1178 on the device. Affected units have specific serial numbers listed in the recall notice: MH353075E2, MH353057E2, MH353067E2, MH353077E2, MH356112G2, MH353056E2, MH356111G2, MH356119G2, MH353065E2, MH356117G2.
Look for the model number 0997-00-1178 on the Cardiosave IABP pneumatic interface module.
Contact Datascope Corp. to confirm if your specific serial number is affected and get instructions.
The recall indicates a potential issue with the safety disk that could lead to slightly reduced inflation during therapy, but it does not specify a risk of serious injury or death. This is a cautionary recall.
Check the model number and serial numbers listed in the recall notice. Contact Datascope Corp. to confirm if your device is affected and get instructions.
Affected units have the model number 0997-00-1178 and specific serial numbers: MH353075E2, MH353057E2, MH353067E2, MH353077E2, MH356112G2, MH353056E2, MH356111G2, MH356119G2, MH353065E2, MH356117G2.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1279-2023 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1279-2023 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.
