Device product
Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
Z-2429-2021
Product summary
- Event
- Event 88372
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1610 units
- Official record key
device-enforcement:Z-2429-2021
Official wording
Reason: Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.
Code information: all codes
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
Derived failure modes
-
Unknown
Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.