Device product
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
Z-2209-2026
Product summary
- Event
- Event 98654
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 53 units
- Official record key
device-enforcement:Z-2209-2026
Official wording
Reason: Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Code information: (1) Model Number: TNG4002-IND; UDI-DI: (1) 00850061601001; Lot numbers: 2510900, 2512938, and 2601944. (2) Model Number: TNG-4007-6pk; UDI-DI: 00850061601001; Lot numbers: 2510900, 2512938, and 2601944
Distribution pattern: US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.
Derived failure modes
-
Unknown
Affected devices exhibited fractures at the distal shaft tip without complete detachment.