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CORDIS S.M.A.R.T. Control" Nitinol Stent System recallZ-1556-2008 · Cordis Corporation · initiated Mar 10, 2008

Terminated All recalls posted in July 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cordis Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Mixed-up of materials/components

What the company is doing

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.

Recall details

Recall number
Z-1556-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 10, 2008
Posted by the FDA
Jul 31, 2008
Recalling firm
Cordis Corporation
Quantity
398 units
Product code
NIO
FDA submissions
P020036
Distribution
Worldwide Distribution --- including USA and countries of Japan and Canada.

Product description

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.

Code information (models, lots, serial numbers)

10 lots. Lot #s: 13326414*, 13326415*, 13327582, 13329185*, 13332369, 13333077*, 13339105*, 13339106*, 13341244, 13343464. (*These six lots have U.S. distribution.)

Other devices under the same FDA submission

38 devices cleared under P020036 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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