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U.S. Department of Health and Human Services

Class 1 Device Recall SUPER TORQUE MB 5F PIG

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  Class 1 Device Recall SUPER TORQUE MB 5F PIG see related information
Date Initiated by Firm July 21, 2021
Create Date September 15, 2021
Recall Status1 Open3, Classified
Recall Number Z-2432-2021
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 532-598C
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 2
Use error
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 26025 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = CORDIS CORP.
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