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Edwards Lifesciences, LLC recalls Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Recalled November 15, 2023 · FDA recall Z-0238-2024 · Edwards Lifesciences
Hazard
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds). · FDA Class II
Units
185
Sold at
OUS: Singapore, Taiwan, Canada
Description
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Product
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Manufacturer(s)
Edwards Lifesciences, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →