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.
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 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.
- 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.
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