Impella CP with SmartAssist recall
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Why was Impella CP with SmartAssist recalled?
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
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?
Product No.: 1000080 (REF 0048-0003); UDI/DI: 00813502012279; Lot/Serial No.: Lot 1798046; Serial numbers: 504354, 504355, 504356, 504357, 504359, 504360, 504361, 504362, 504363.
- Product
- Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
- Recalling firm
- Abiomed, Inc.
- Quantity
- 9 units
- Distribution
- Domestic only: FL, MA, OH TX.
- Recall date
- July 24, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)