The Recall Desk
SevereFDA (Devices)·Z-2432-2021·Announced 2021-09-22

Cordis SUPER TORQUE MB Angiographic Catheter Recalled for Device Entrapment Risk

Cordis Corporation recalls SUPER TORQUE MB angiographic catheters worldwide due to risk of entrapment between endovascular devices and vessel wall, potentially causing marker band dislodgement.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall. The hazard involves risk of catheter entrapment and marker band dislodgement, which could compromise device safety and lead to adverse patient outcomes. However, no deaths, serious injuries, or hospitalizations are reported in the source document.

Plain-English summary

Cordis Corporation has recalled the SUPER TORQUE MB angiographic catheter (REF 532-598C) with marker bands. The recall affects approximately 26,025 units distributed worldwide, including the United States, Canada, and Europe.

The hazard involves potential entrapment of the catheter between endovascular devices and the vessel wall. When entrapment occurs, the marker bands may move or become dislodged, which could compromise the clinical effectiveness and safety of the device during angiographic procedures.

This is a Class I recall, the FDA's most serious classification. Physicians and healthcare facilities using this catheter should implement alternative approaches for affected procedures and contact Cordis Corporation for information about recalled units and potential replacements.

The recalled product

Product
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
Manufacturer
Cordis Corporation
Category
Medical Device — Angiographic Catheter
Hazard
Affected units
26,025

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

See all →