Reported Mar 29, 2023 · Ongoing
Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
Datascope Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Datascope Corp. · 1300 Macarthur Blvd · Mahwah, NJ · 07430-2052
Is this the product you have?
- Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
- Lot codes and dates
- Serial Numbers
669 of 669 codes
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
- Serial Numbers
- Amount recalled
- 669 safety disks
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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