The Recall Desk
HighFDA (Devices)·Z-2431-2021·Announced 2021-09-22

Cordis Angiographic Catheter Recalled for Marker Band Dislodgement Risk

Cordis is recalling angiographic catheters that may become entrapped between devices and vessel walls, risking marker band dislodgement during vascular procedures. Approximately 71,330 units were distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class I medical device recall. However, the source text contains no reports of actual injury or illness, and the hazard is prospective (catheter 'may allow' entrapment). Per the rubric, Class I recalls without reported harm and theoretical hazards are capped at score 3.

Plain-English summary

Cordis Corporation is recalling the SUPER TORQUE MB 5F PIG Angiographic Catheter (REF 532-598B) used in angiographic procedures.

The catheter may become entrapped between endovascular devices and the vessel wall during use. This entrapment can cause the catheter's marker band to move or become dislodged.

Approximately 71,330 units were distributed worldwide, including throughout the United States, Canada, and Europe. The recall applies to all product code lots.

The recalled product

Product
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
Manufacturer
Cordis Corporation
Category
Medical Device — Angiographic Catheter
Hazard
Affected units
71,330

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • all codes

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Cordis Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Cordis Corporation

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Same hazard · entrapment

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