Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C

Recall Insight

This FDA Devices action (record #Z-2432-2021) was formally reported on September 22, 2021, with the manufacturer initiating the action on July 21, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Cordis Corporation is listed as the recalling firm, operating out of Miami Lakes, FL. Federal records indicate 26025 units units are affected.

The documented reason for this recall is: 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 l… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.