Arrow AC3 Optimus Intra-Aortic Balloon Pump recall
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
Why was Arrow AC3 Optimus Intra-Aortic Balloon Pump recalled?
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
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?
UDI/DI (01) 0 0801902 08496 5, (01) 0 0801902 08496 6, All Lot/Serial Numbers
- Product
- Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
- Recalling firm
- ARROW INTERNATIONAL Inc.
- Quantity
- N/A
- Distribution
- Worldwide
- Recall date
- December 21, 2022
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)