FDA Device recall Z-0238-2024
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
- FDA Device
- Class II
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 by Edwards Lifesciences, citing inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0238-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-07 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Edwards Lifesciences |
| Distribution | n/a |
Product
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Reason
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Identifiers
| code_info | UDI-DI: 00690103043532, Lot: 64936927 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0238-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.