The Recall Desk
CriticalFDA (Devices)·Z-1275-2013·Announced 2013-05-22

Cook Medical Recalls Zilver PTX Drug-Eluting Peripheral Stent

Cook Medical is recalling Zilver PTX Drug-Eluting Peripheral Stents due to delivery system fractures and tip separations that resulted in one death.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states that one death occurred in cases where a tip separation happened, which meets the rubric criterion for a score of 5 (Critical) regardless of other factors.

Plain-English summary

Cook Medical is recalling the Zilver PTX Drug-Eluting Peripheral Stent, a medical device used to treat peripheral artery disease in the thigh. The recall is due to a small number of complaints regarding the delivery system, specifically fractures of the inner catheter after stent deployment and separation of the inner catheter tip section.

The source text reports 13 complaints with an occurrence rate of 0.043%. Two adverse events occurred in cases where a tip separation happened, including one death. The affected product is the 7 mm X 80mm; 125 cm size, sterile, and prescription-only. The recall covers 535 units in the USA, with worldwide distribution including Japan, Europe, Brazil, and Australia.

Healthcare providers and patients should contact Cook Medical or their local FDA office for further instructions on how to handle the recalled devices. The recall number is Z-1275-2013.

The recalled product

Product
Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an art
Manufacturer
Cook, Inc.
Category
Medical Device — Vascular Stent
Hazard
Affected units
535

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 (2)

  • REF ZIV6-35-125-7-80-PTX
  • UDI 10827002248950 all lots distributed through 4/16/13

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Cook, Inc. 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 2 products in this recall →

Related recalls

Same manufacturer · Cook, Inc.

See all →

Same hazard · device fracture

See all →