Official recall notice
FDA DeviceClass IINotable
TufTex Over-the-Wire Embolectomy Catheter Recall (Oct 2026)
Product: TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
- Recall date
- 2026-10-14
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
Product description
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
Affected products
Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;