Recalls / —

—#188531

Product

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

FDA product code

DQO — Catheter, Intravascular, Diagnostic

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K992347

Affected lot / code info

all codes

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Cordis Corporation

Address

14201 NW 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.

Timeline

Recall initiated

2021-07-21

Posted by FDA

2021-09-15

Terminated

2024-09-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #188531. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.