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.
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 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…
- Manufacturer
- Cook, Inc.
- Category
- Medical Device — Vascular Stent
- 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.
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