Cordis Corporation: Medical Device Recall in 2016 - (Recall #: Z-1947-2016)

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:

Cordis PRECISE (R) RX Nitinol Stent System (Biliary)

Product Classification:

Class II

Date Initiated: May 4, 2016

Date Posted: June 22, 2016

Recall Number: Z-1947-2016

Event ID: 74097

Reason for Recall:

Inability to deploy the stent or partial stent deployment.

Status: Terminated

Product Quantity: 4,400 units in US; 3,100 units to Foreign Countries

Code Information:

Catalog Number: P05030RXB, Lot Number: 17241836; Catalog Number: P09030RXB, Lot Number: 17241838; Catalog Number: P07030RXB, Lot Number : 17291878; Catalog Number: P07040RXB, Lot Number: 17291879; Catalog Number: P06040RXB, Lot Number: 17415243.

Distribution Pattern:

NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.

Voluntary or Mandated:

Voluntary: Firm initiated