Fogarty Thru-Lumen Embolectomy Catheter recall
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Why was Fogarty Thru-Lumen Embolectomy Catheter recalled?
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
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: 00690103043532, Lot: 64936927
- Product
- Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 185
- Distribution
- OUS: Singapore, Taiwan, Canada
- Recall date
- November 15, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)