Zilver¿ 518RX Vascular Stent with Rapid Exchange recall
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
Why was Zilver¿ 518RX Vascular Stent with Rapid Exchange recalled?
Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. Failure of this joint during a procedure may result in a partial stent deployment. The clinical effect of a partial deployment may be a need for surgical intervention, or may result in vessel trauma or an embolic event
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Prefix ZIVX5. All Lots
- Product
- Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
- Recalling firm
- Cook Medical Incorporated
- Quantity
- 753
- Distribution
- Nationwide Worldwide
- Recall date
- February 3, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)