The Recall Desk
SevereFDA (Devices)·Z-2428-2021·Announced 2021-09-22

Angiographic Catheter Recall: Cordis SUPER TORQUE Entrapment and Dislodgement Risk

Cordis is recalling its SUPER TORQUE MB Angiographic Catheter worldwide because it may become entrapped between endovascular devices and the vessel wall. This entrapment can cause marker band movement or 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: This is classified as FDA Class I, which establishes a minimum severity score of 4 per the rubric. Although no injuries or deaths have been reported, Class I recalls represent serious potential hazards to patient safety.

Plain-English summary

Cordis Corporation is recalling the SUPER TORQUE MB Angiographic Catheter (with marker bands) worldwide, including distribution in the United States, Canada, and Europe. A total of 45 units are affected.

The catheter may become entrapped between endovascular devices and the vessel wall during endovascular procedures. This entrapment can lead to movement or dislodgement of the marker bands.

Healthcare facilities using this product should review their inventory for affected units and contact Cordis Corporation for guidance on proper use, handling, and any necessary steps for affected devices.

The recalled product

Product
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
Manufacturer
Cordis Corporation
Category
Medical Device — Angiographic Catheter
Hazard
  • entrapment
  • dislodgement

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.

Related recalls

Same category