—#188529

Product

Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB

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 #188529. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.