Tangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
Tangent Endoscopy is recalling its Tangent Single Use Digital Catheter (models TNG4002-IND and TNG-4007-6pk) due to fractures observed at the distal shaft tip without complete detachment, posing a risk during endoscopic procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall. The hazard—distal shaft fractures—involves a risk-of-harm to patients in an endoscopic procedure context, and no reported illnesses or injuries are stated in the source text, placing it at the High level per the rubric.
Plain-English summary
Tangent Endoscopy, LLC is recalling the Tangent Single Use Digital Catheter, model numbers TNG4002-IND and TNG-4007-6pk, due to fractures found at the distal shaft tip without complete detachment. A total of 53 units have been distributed nationwide across North Carolina, Arizona, and Nevada.
The affected devices include model TNG4002-IND with UDI-DI 00850061601001 and lot numbers 2510900, 2512938, and 2601944, as well as model TNG-4007-6pk with the same UDI-DI and lot numbers. These fractures could compromise the integrity and functionality of the catheter during use in endoscopic procedures.
Healthcare providers and patients who have received these devices should contact Tangent Endoscopy, LLC for guidance on device replacement or proper handling. Facilities should verify receipt against the affected lot numbers and discontinue use of affected units.
The recalled product
- Product
- Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.
- Manufacturer
- TANGENT ENDOSCOPY, LLC
- Affected units
- 53
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- (1) Model Number: TNG4002-IND
- UDI-DI: (1) 00850061601001
- Lot numbers: 2510900
- 2512938
- and 2601944. (2) Model Number: TNG-4007-6pk
- UDI-DI: 00850061601001
- and 2601944
Distribution
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