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Terminated

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

FDA Recall Z-2432-2021 · Posted 2021-09-15

Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeDQO
Date Initiated2021-07-21
Date Terminated2024-09-09
Product Quantity26025 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992347CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDSCordis Corp. · 1999-10-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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