The Recall Desk
HighFDA (Devices)·Z-1507-2013·Announced 2013-06-12

Cordis Recalls FLEXSTENT Biliary Stents Due to Pouch Defects

Cordis Corporation is recalling 23 units of FLEXSTENT Biliary Self-Expanding Stent Systems because holes or tears can form in the inner or outer pouches.

What this means for you

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 involves a medical device with a structural defect (pouch tears) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cordis Corporation is recalling 23 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-B1 and FLX-80150-B1.

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 compromise the integrity of the stent system during use.

The affected units were distributed nationwide in the United States and in the Czech Republic, Italy, Netherlands, and New Zealand. Healthcare providers and facilities should stop using the affected units and contact Cordis Corporation for further instructions.

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
23

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-B1
  • FLX-60030-B1
  • FLX-70030-B1
  • FLX-80030-B1
  • FLX-50040-B1
  • FLX-60040-B1
  • FLX-70040-B1
  • FLX-80040-B1
  • FLX-50060-B1
  • FLX-60060-B1
  • FLX-70060-B1
  • FLX-80060-B1
  • FLX-50080-B1
  • FLX-60080-B1
  • FLX-70080-B1
  • FLX-80080-B1
  • FLX-50100-B1
  • FLX-60100-B1
  • FLX-70100-B1
  • FLX-80100-B1

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 →

Related recalls

Same manufacturer · Cordis Corporation

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Same hazard · structural defect

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