Cook Medical Incorporated: Medical Device Recall in 2016 - (Recall #: Z-0689-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System

Product Classification:

Class II

Date Initiated: December 22, 2015

Date Posted: February 3, 2016

Recall Number: Z-0689-2016

Event ID: 72965

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

Status: Terminated

Product Quantity: 753

Code Information:

Catalog Prefix ZIVX5. All Lots

Distribution Pattern:

Nationwide Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated