The Recall Desk
SevereFDA (Devices)·Z-2430-2021·Announced 2021-09-22

Cordis SUPER TORQUE Angiographic Catheter Recalled for Entrapment Risk

Cordis is recalling the SUPER TORQUE MB angiographic catheter (18,730 units) due to risk of entrapment between endovascular devices and vessel wall, which can cause marker band movement or dislodgement. Units were distributed worldwide.

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 has classified this as a Class I recall, the highest classification for medical devices. The potential for device entrapment and marker band dislodgement during critical endovascular procedures, combined with the FDA's Class I designation, warrants a Severe rating.

Plain-English summary

Cordis Corporation is recalling the SUPER TORQUE MB 5F PIG angiographic catheter (REF 532-598A) due to a defect that may allow the catheter to become entrapped between endovascular devices and the vessel wall during use. When entrapped, the marker bands on the catheter may move or become dislodged, potentially compromising device safety and effectiveness during endovascular procedures.

The recalled devices affect 18,730 units distributed worldwide, including throughout the United States, Canada, and Europe. The recall applies to all code numbers for this product.

Healthcare providers and institutions should seek guidance from Cordis Corporation regarding affected units.

The recalled product

Product
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A
Manufacturer
Cordis Corporation
Category
Medical Device — Vascular Catheter
Hazard
  • device-entrapment
  • marker-band-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