—#69267

Product

CORDIS S.M.A.R.T. Control" Nitinol Stent System Model Number(s): C10040SL, Manufactured in Mexico. Indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease.

FDA product code: NIO — Stent, Iliac
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P020036
Affected lot / code info: 10 lots. Lot #s: 13326414*, 13326415*, 13327582, 13329185*, 13332369, 13333077*, 13339105*, 13339106*, 13341244, 13343464. (*These six lots have U.S. distribution.)

Why it was recalled

Data transcription error. The 10 affected lots of Catalog Number C10040SL were manufactured with a prior version of the guidewire lumen material, which is not validated with the current manufacturing process. This condition may result in a separation of the device. If a separation was to occur, and the separated fragment of lumen material was not retrieved on the guidewire, blockage of the vessel

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

A letter (RE: Medical Device Recall) dated March 11, 2008, and Acknowledgement Form was sent overnight to the following 6 individuals in each account: Dir. Cardiac Cath Lab, Dir. Radiology Services, Dir. Vascular Services, Risk Manager, Materials Dir., Hospital Administrator; requesting that the affected product be set aside, and that the form be reviewed, signed, and faxed back to Cordis. Affected product is to be either returned or the local sales rep should the contacted to facilitate the return of the affected product. All product will be replaced. Customer Service can be contacted if there are additional questions relative to product return, replacement, or availability.

Recalling firm

Firm: Cordis Corporation
Address: 14201 NW 60th Avenue, Miami Lakes, Florida 33014

Distribution

Distribution pattern: Worldwide Distribution --- including USA and countries of Japan and Canada.

Timeline

Recall initiated: 2008-03-10
Posted by FDA: 2008-07-31
Terminated: 2009-10-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69267. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.