The Recall Desk
CriticalFDA (Devices)·Z-1274-2013·Announced 2013-05-22

Cook Medical Recalls Zilver PTX Drug-Eluting Peripheral Stent Due to Catheter Fracture

Cook Medical is recalling Zilver PTX Drug-Eluting Peripheral Stents because the delivery system's inner catheter can fracture or separate after deployment, a defect linked to one reported 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 reports one death associated with the device defect, which mandates a Critical severity score of 5 according to the rubric.

Plain-English summary

Cook Medical is recalling the Zilver PTX Drug-Eluting Peripheral Stent (6 mm X 80mm; 125 cm) due to a defect in the delivery system. The company received 13 complaints regarding fractures of the delivery system's inner catheter after the stent was deployed, as well as separation of the inner catheter tip section. The occurrence rate for these issues is 0.043%.

The recall covers 1,057 units distributed in the United States, as well as units distributed worldwide in Japan, Europe, Brazil, and Australia. The affected product is identified by REF ZIV6-35-125-6-80-PTX and REFG24890, with UDI 10827002248905. All lots distributed prior to April 16, 2013, are included in this recall.

Two adverse events occurred in cases where a tip separation happened, including one death. The Zilver PTX stent is a self-expanding metal mesh tube coated with the drug Paclitaxel, used to hold open narrowed arteries in the thigh to improve blood flow. Consumers and healthcare providers should stop using the affected devices and contact Cook Medical for further instructions.

The recalled product

Product
Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 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 ar
Manufacturer
Cook, Inc.
Category
Medical Device — Vascular Stent
Hazard
Affected units
1,057

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 ZIV6-35-125-6-80-PTX
  • REFG24890 UDI 10827002248905 All lots distributed prior to 4/16/2013

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.

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Same hazard · device fracture

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