Cook Medical Recalls Zilver 518RX Vascular Stent Delivery Systems
Cook Medical is recalling 753 Zilver 518RX Vascular Stent delivery systems because a manufacturing defect may cause the catheter joint to separate during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 recall is classified as FDA Class II and involves a structural defect in a medical device that may result in vessel trauma, embolic events, or the need for surgical intervention, meeting the criteria for a Severe rating.
Plain-English summary
Cook Medical Incorporated is recalling 753 units of the Zilver 518RX Vascular Stent with Rapid Exchange Delivery System. The recall covers all lots with the catalog prefix ZIVX5. The products were distributed nationwide and worldwide.
The recall is due to a manufacturing defect where the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications. This joint may separate during deployment. If the joint fails during a procedure, it may result in a partial stent deployment.
The clinical effects of a partial deployment may include the need for surgical intervention, vessel trauma, or an embolic event. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
- Manufacturer
- Cook Medical Incorporated
- Category
- Medical Device — Vascular Stent
- Affected units
- 753
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)
- Catalog Prefix ZIVX5. All Lots
Distribution
Distributed nationwide across the United States.
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