CORDIS S.M.A.R.T. Control" Nitinol Stent System Model Number(s): C10040SL, Manufactured in Mexico. Indicated for improvi

FDA device recall Z-1556-2008 · posted 2008-07-31 · Terminated

Recall details

Recalling firm

Cordis Corporation

Reason for recall

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

Action taken

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.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

NIO

Quantity affected

398 units

Distribution

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

Date initiated

2008-03-10

Date posted

2008-07-31

Date terminated

2009-10-01

Location

Miami Lakes, FL