Z-2429-2021 Class I Terminated
FDA device recall Z-2429-2021 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: 1610 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
- 1610 units
Product Description
Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
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