FDA Device recall Z-0117-2027
TufTex¿ Over-the-Wire Embolectomy Catheter
- FDA Device
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of TufTex¿ Over-the-Wire Embolectomy Catheter by Lemaitre Vascular, citing devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0117-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-28 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Lemaitre Vascular |
| Distribution | US |
Product
TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Reason
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
Identifiers
| code_info | Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
Other recalls by Lemaitre Vascular
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FDA Device · Class II · 2026-03-25 · Lemaitre Vascular - Artegraft¿ Collagen Vascular Graft
FDA Device · Class II · 2025-10-29 · Lemaitre Vascular - Artegraft Collagen Vascular Graft
FDA Device · Class II · 2025-10-15 · Lemaitre Vascular - Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) A…
FDA Device · Class II · 2025-10-08 · Lemaitre Vascular - TufTex Over-the-Wire Embolectomy Catheter
FDA Device · Class II · 2025-05-21 · Lemaitre Vascular
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0117-2027%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.