Device Recall CORDIS S.M.A.R.T. Control" Nitinol Stent System 의 리콜

Recall

47347

Class 2

Z-1556-2008

2008-03-10

2008-07-31

Terminated

United States

2009-10-01

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69267

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.

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.