The Recall Desk
HighFDA (Devices)·Z-0996-2020·Announced 2020-02-12

Gore Excluder Iliac Branch Endoprosthesis Recalled for Catheter Separation

W. L. Gore & Associates is recalling the GORE EXCLUDER Iliac Branch Endoprosthesis due to reports of leading end catheter component separations.

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 high-risk medical device with a structural defect (catheter separation) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

W. L. Gore & Associates Inc. is recalling the GORE EXCLUDER Iliac Branch Endoprosthesis (IBE). The recall involves 23,212 units distributed in the United States and multiple international markets, including Australia, Canada, and the United Kingdom.

The recall was initiated because the firm received reports of leading end catheter component separations. The affected products are identified by specific catalog numbers (PLC*, PLA*, PLL*, RLT23*, RLT26*, RLT28*, RLT31*, RLT35*, HGB*, and CEB*) and are not limited to specific lot or serial numbers.

Healthcare providers and patients should contact W. L. Gore & Associates Inc. for further instructions regarding the affected devices.

The recalled product

Product
GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
Manufacturer
W. L. Gore & Associates Inc.
Category
Medical Device — Vascular Endoprosthesis
Hazard
Affected units
23,212

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 (9)

  • -Catalog numbers PLC*
  • PLA*
  • PLL*
  • RLT23*
  • RLT26*
  • RLT28*
  • RLT31*
  • RLT35*
  • HGB*

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by W. L. Gore & Associates Inc. 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 2 products in this recall →

Related recalls

Same manufacturer · W. L. Gore & Associates Inc.

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Same hazard · component separation

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