Device product
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Z-2033-2017
Product summary
- Event
- Event 76939
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,252 eaches
- Official record key
device-enforcement:Z-2033-2017
Official wording
Reason: Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.
Code information: Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.