FDA Device recall Z-1750-2025
TufTex Over-the-Wire Embolectomy Catheter
- FDA Device
- Class II
- ongoing
- Published 2025-05-21
On 2025-05-21 the FDA classified a Class II recall of TufTex Over-the-Wire Embolectomy Catheter by Lemaitre Vascular, citing during internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1750-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-11 |
| Published | 2025-05-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Lemaitre Vascular |
| Distribution | US |
Product
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1651-88J.
Reason
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Identifiers
| code_info | UDI-DI: 00840663100651, 00840663100668, 00840663100675, 00840663100682, 00840663100699, 00840663100705, 00840663100712,…UDI-DI: 00840663100651, 00840663100668, 00840663100675, 00840663100682, 00840663100699, 00840663100705, 00840663100712, 00840663100729, 00840663107551, 00840663100736, 00840663100743, 00840663100750, 00840663100767, 00840663100774, 00840663100781, 00840663100798, 00840663100804, 00840663100811, 00840663100828, 00840663100835, 00840663107568, 00840663100842, 00840663100859, 00840663100866. Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88. Lots not expired with the following prefix: OTW, QOT, XOT, COT |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1750-2025%22
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