Z-1947-2016Class II

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

Name: Z-1947-2016 Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
Creator: Cordis Corporation
Published: 2016-05-04
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2016-05-04 / Terminated / root cause: design

FDA source

Cordis Corporation began a recall of Cordis PRECISE (R) RX Nitinol Stent System (Biliary) on 2016-05-04. FDA classified it as Class II and gives the reason as "Inability to deploy the stent or partial stent deployment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1947-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-04
Posted: 2016-06-10
Terminated: 2019-07-26
Recalling firm: Cordis US Corp.
Product: Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
Product code: NIM Stent, Carotid
Reason for recall: Inability to deploy the stent or partial stent deployment.
Root cause tag: design
FDA root cause: Component design/selection
Action: Cordis sent an Urgent Medical Device Recall (Removal) letter dated May 4, 2016, to all affected customers. Action to be taken by the customer: 1) Immediately check your inventory to confirm whether you have any units from affected lots in your possession. Identify and set aside any units from the affected lot in a manner that ensures the affected product will not be used. Check all storage and usage locations. 2) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form. Note that you will receive multiple letters and Acknowledgement Forms if your facility received affected product at both a legacy Ship-To account number and a Cardinal Health Ship To account number at the same address. In that scenario, please sign and return both forms. 3) Return all affected products to the address listed on the form, with reference to Return Authorization Number ( i.e. RA #)#which is listed on the form. Replacement devices will be shipped after the affected product is returned. Consigned Inventory will also be replaced after the product is returned and an analysis of SKU mix needed to properly support the customer is conducted. 4) Share this letter with others in your facility who need to be made aware of this recall, including the areas in some facilities where these products are frequently used (see list above) Contact any other facilities that have been provided with units of affected lots. Maintain awareness of this notice until all affected product has been returned to Cordis. 5) Keep a copy of this notice with any affected product until returned. For questions related to assistance returning product or billing concerns or questions please contact your sales representative or Cordis Customer Service at 1-800-327-7714 Option 1, Monday through Friday from 7:00AM to 8:00 PM EDT.
Quantity in commerce: 4,400 units in US; 3,100 units to Foreign Countries
Distribution: NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1947-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1946-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-10
Z-1947-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-22	2016-06-10

Product code NIM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)