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.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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…
- Manufacturer
- Cook, Inc.
- Category
- Medical Device — Vascular Stent
- 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.
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