Skip to content
Recall Observatory FDA recall evidence

Device product

Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip

Z-1418-2023

February 23, 2023

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 91840
Status
Ongoing
Classification
Class II
Quantity
65.9 boxes (373 pieces)
Official record key
device-enforcement:Z-1418-2023

Official wording

Reason: There have been complaints that the clip did not come out of the tube sheath during the procedure.

Code information: 1) UDI-DI 14953170353106; Model HX-201LR-135; Lot 1ZV 2) UDI-DI 14953170353113; Model HX-201UR-135; Lot 23V 3) UDI-DI 14953170353120; Model HX-201UR-135; Lot 24V 4) UDI-DI 14953170353168; Model HX-201UR-135L; Lot 24V

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There have been complaints that the clip did not come out of the tube sheath during the procedure.