Device product
Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
Z-2174-2017
Product summary
- Event
- Event 76921
- Status
- Terminated
- Classification
- Class II
- Quantity
- 792 units
- Official record key
device-enforcement:Z-2174-2017
Official wording
Reason: There is a risk that the pinion gear in the device could fail under extreme use cases.
Code information: N91U0W, N91U0X, N91L2P, N91N1J, and N91N2G
Distribution pattern: Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.
Derived failure modes
-
Unknown
There is a risk that the pinion gear in the device could fail under extreme use cases.