Recall Z-0689-2016— Cook Medical Incorporated
Class II · Terminated
Class II FDA medical device recall by Cook Medical Incorporated, initiated 2015-12-22, terminated 2017-07-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System. Reason: 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.
- Recalling firm
- Cook Medical Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-22
- Terminated
- 2017-07-25
- Firm location
- Bloomington, IN, United States
Product description
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.