Reported Nov 15, 2023 · Ongoing
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- Fogarty Thru-Lumen Embolectomy Catheter
- REF12TLW805F35
- Lot codes and dates
- UDI-DI00690103043532
- Lot64936927
- Amount recalled
- 185
Why it was recalled
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
This product could cause temporary or reversible health problems — stop using it.
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