Device product
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Z-0238-2024
Product summary
- Event
- Event 93172
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 185
- Official record key
device-enforcement:Z-0238-2024
Official wording
Reason: Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Code information: UDI-DI: 00690103043532, Lot: 64936927
Distribution pattern: OUS: Singapore, Taiwan, Canada
Derived failure modes
-
Unknown
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).