Z-2432-2021 Class I Terminated
FDA device recall Z-2432-2021 was initiated by Cordis Corporation on July 21, 2021 and is designated Class I. Reason for recall: 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 vesse… The recall status is terminated (terminated September 9, 2024). Affected quantity: 26025 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 22, 2021
- Initiation Date
- July 21, 2021
- Termination Date
- September 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26025 units
Product Description
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
Code Information
all codes