The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1509-2013·Announced 2013-06-12

Cordis Recalls FLEXSTENT Biliary Stents Due to Pouch Defects

Cordis is recalling 1,357 FLEXSTENT Biliary Self-Expanding Stent Systems because holes or tears can form in the inner or outer pouches.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect in a medical device used for palliation of malignant strictures, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Cordis Corporation is recalling 1,357 units of the FLEXSTENT Biliary Self-Expanding Stent System. The product is indicated for the palliation of malignant strictures in the biliary tree. The recall covers 27 specific catalog numbers, including FLX-50030-B2 and FLX-80150-B2.

The recall was initiated because holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch. This defect could potentially compromise the integrity of the device during use.

The affected units were distributed worldwide, including nationwide in the United States and in the Czech Republic, Italy, Netherlands, and New Zealand. Specific US states listed include AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, and WV. Healthcare providers and patients should contact Cordis Corporation for further instructions on how to proceed with the recall.

The recalled product

Product
FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
Manufacturer
Cordis Corporation
Category
Medical Device — Biliary Stent
Hazard
Affected units
1,357

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 27 Catalog Numbers FLX-50030-B2
  • FLX-60030-B2
  • FLX-70030-B2
  • FLX-80030-B2
  • FLX-50040-B2
  • FLX-60040-B2
  • FLX-70040-B2
  • FLX-80040-B2
  • FLX-50060-B2
  • FLX-60060-B2
  • FLX-70060-B2
  • FLX-80060-B2
  • FLX-50080-B2
  • FLX-60080-B2
  • FLX-70080-B2
  • FLX-80080-B2
  • FLX-50100-B2
  • FLX-60100-B2
  • FLX-70100-B2
  • FLX-80100-B2

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Cordis Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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