The Recall Desk
HighFDA (Devices)·Z-1508-2013·Announced 2013-06-12

Cordis Recalls FLEXSTENT Stent Systems Due to Pouch Integrity Issues

Cordis is recalling 784 FLEXSTENT stent systems because holes or tears can form in the protective pouches, potentially compromising the device.

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 is classified as FDA Class II, and the defect involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Cordis Corporation is recalling 784 units of the FLEXSTENT Femoropopliteal Self-Expanding Stent System. The recall is due to a defect where 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 were distributed worldwide, including nationwide in the United States and in the Czech Republic, Italy, the Netherlands, and New Zealand. The recall covers 28 specific catalog numbers ranging from CAC-50030-V2 to CAC-80150-V2.

This is an FDA Class II recall. The source text does not report any specific injuries or illnesses associated with this defect. Healthcare providers and patients should contact Cordis Corporation for further instructions on how to handle the affected 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
784

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)

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