FDA recall Z-0238-2024

Edwards Lifesciences, LLC · Class II · device

Product

Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

Reason for recall

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

Distribution

OUS: Singapore, Taiwan, Canada

Key facts

Status
Ongoing
Initiation date
2023-09-07
Report date
2023-11-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0238-2024