Class 1 Device Recall SUPER TORQUE MB 5F PIG

• Date Initiated by Firm: July 21, 2021
• Date Posted: September 15, 2021
• Recall Status: Terminated on September 09, 2024
• Recall Number: Z-2430-2021
• Recall Event ID: 88372
• 510(K)Number: K992347
• Product Classification: Catheter, intravascular, diagnostic - Product Code DQO
• Product: Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A
• Code Information: all codes
• Recalling Firm/ Manufacturer: Cordis Corporation; 14201 NW 60th Ave; Miami Lakes FL 33014-2802
• For Additional Information Contact: 786-313-2000
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: The firm disseminated an Urgent Medical Device Field Correction notice beginning on 07/21/2021. The letter described the problem and provided recommendations for clinical use found in the instructions for use.
• Quantity in Commerce: 18730 units
• Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQO