The Recall Desk
Agency classClass IOur severity:SevereFDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band…"

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 →

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