medical Class II Updated 2023-11-15

Edwards Lifesciences, LLC recalls Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

Recalled Product

Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35


Hazard / Issue

Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).

Issued by

FDA

Distribution: OUS: Singapore, Taiwan, Canada
Lot/Code Info: UDI-DI: 00690103043532, Lot: 64936927
View official government recall

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