Z-1279-2023 Class II Ongoing
FDA device recall Z-1279-2023 was initiated by Datascope Corp. on February 28, 2023 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- March 29, 2023
- Initiation Date
- February 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product Description
Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
Reason for Recall
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.
Distribution Pattern
Distribution list not yet provided.
Code Information
Serial Numbers: MH353075E2 MH353057E2 MH353067E2 MH353077E2 MH356112G2 MH353056E2 MH356111G2 MH356119G2 MH353065E2 MH356117G2