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Recall Observatory FDA recall evidence

Device product

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

Z-1947-2016

May 04, 2016

Class II

Product summary

Firm
Cordis Corporation
Event
Event 74097
Status
Terminated
Classification
Class II
Quantity
4,400 units in US; 3,100 units to Foreign Countries
Official record key
device-enforcement:Z-1947-2016

Official wording

Reason: Inability to deploy the stent or partial stent deployment.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Inability to deploy the stent or partial stent deployment.