The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1511-2013·Announced 2013-06-12

Cordis FLEXSTENT Stent System Recalled for Pouch Integrity Defects

Cordis Corporation is recalling 310 FLEXSTENT stent systems because holes or tears can form in the protective pouches, potentially compromising the device.

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 defect involves a structural integrity issue (pouch tears) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Cordis Corporation is recalling 310 units of the FLEXSTENT Femoropopliteal Self-Expanding Stent System. 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.

The FLEXSTENT system is indicated for the treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions. The affected units are distributed worldwide, including nationwide in the United States and in the Czech Republic, Italy, the Netherlands, and New Zealand. The recall covers 32 specific catalog numbers, ranging from FLX-50030-V2 to FLX-80200-V2.

Healthcare providers and patients should stop using the affected FLEXSTENT systems and contact Cordis Corporation for further instructions on how to return or replace the devices.

The recalled product

Product
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
Manufacturer
Cordis Corporation
Category
Medical Device — Vascular Stent
Hazard
Affected units
310

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)

  • 32 Catalog Numbers FLX-50030-V2
  • FLX-60030-V2
  • FLX-70030-V2
  • FLX-80030-V2
  • FLX-50040-V2
  • FLX-60040-V2
  • FLX-70040-V2
  • FLX-80040-V2
  • FLX-50060-V2
  • FLX-60060-V2
  • FLX-70060-V2
  • FLX-80060-V2
  • FLX-50080-V2
  • FLX-60080-V2
  • FLX-70080-V2
  • FLX-80080-V2
  • FLX-50100-V2
  • FLX-60100-V2
  • FLX-70100-V2
  • FLX-80100-V2

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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