Cardiosave Intra-Aortic Balloon Pump recall
Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
Why was Cardiosave Intra-Aortic Balloon Pump 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: MH353075E2 MH353057E2 MH353067E2 MH353077E2 MH356112G2 MH353056E2 MH356111G2 MH356119G2 MH353065E2 MH356117G2
- Product
- Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
- Recalling firm
- Datascope Corp.
- Quantity
- 10
- Distribution
- Distribution list not yet provided.
- Recall date
- March 29, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)