Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A
This recall has been terminated (originally issued September 15, 2021).
- Company
- Cordis Corporation
- Recall Initiated
- July 21, 2021
- Posted
- September 15, 2021
- Terminated
- September 9, 2024
- Recall Number
- Z-2430-2021
- Quantity
- 18730 units
- Firm Location
- Miami Lakes, FL
- Official Source
- View on FDA website ↗
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
Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
Lot / Code Info
all codes
Root Cause
Device Design
Action Taken
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.
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