The Recall Desk
SevereFDA (Devices)·Z-2429-2021·Announced 2021-09-22

Cordis Angiographic Catheter Recall Due to Potential Marker Band Dislodgement

Cordis is recalling approximately 1,610 SUPER TORQUE PIG PIGTAIL SPECIAL angiographic catheters worldwide because the device can become entrapped between endovascular devices and the vessel wall, potentially causing 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 an FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls require a minimum classification of Severe (score 4). The source text does not report any known deaths, injuries, or illnesses.

Plain-English summary

Cordis Corporation is recalling all units of the SUPER TORQUE PIG PIGTAIL SPECIAL 5F angiographic catheter (REF SRD7040MB), affecting approximately 1,610 devices. The products have been distributed worldwide, including the United States, Canada, and Europe, and all code numbers are affected.

During clinical use, the catheter can become entrapped between endovascular devices and the vessel wall. This entrapment may cause the device's marker bands to move or become dislodged, potentially affecting device functionality during endovascular procedures.

The recalled product

Product
Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
Manufacturer
Cordis Corporation
Category
Medical Device — Angiographic 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