FDA-Device2023-11-15Class II
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Edwards Lifesciences, LLC
Hazard
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Sold states
OUS: Singapore, Taiwan, Canada
Affected count
185
Manufactured in
1 Edwards Way, Irvine, CA, United States
Products
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0238-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief