Recall Z-0117-2027
- Recall number
- Z-0117-2027
- Event number
- 99836
- Firm
- LeMaitre Vascular, Inc.
- Firm FEI
- 1220948
- Product code
- DXE
- Status
- Open, Classified
- Initiated
- 2026-08-28
- Posted
- 2026-10-07
- Root cause
- Under Investigation by firm
- 510(k) numbers
- K022145, K892410, K972511, K864062, K974335, K954760, K850015, K840198, K914880, K770714, K202049, K961992, K920823, K213771, K780762, K955125, K894681, K972623, K992933, K893680, K950586, K240078, K961883, K883852, K970657, K902327, K100840, K992368, K973465, K935405
Product#
TufTex Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Reason for Recall#
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.