Agency classClass IIOur severity:Severe FDA (Devices)·Z-0995-2020·Announced 2020-02-12

Gore Excluder AAA Endoprosthesis Recalled for Catheter Separation

W. L. Gore & Associates is recalling GORE EXCLUDER AAA Endoprosthesis devices 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (catheter separation) in a medical device, which meets the criteria for a Severe rating.

Plain-English summary

W. L. Gore & Associates Inc. is recalling the GORE EXCLUDER AAA Endoprosthesis. The recall is being conducted because the firm has received reports of leading end catheter component separations.

The recall involves 25,586 units of the device. The affected products are distributed in the United States and various international locations, including Australia, Canada, and the United Kingdom. The recall is not specific to any particular lot or serial numbers.

Healthcare providers and patients should contact W. L. Gore & Associates Inc. for further instructions regarding the recall and potential replacement or repair of the devices.

The recalled product

Product: GORE¿ EXCLUDER¿ AAA Endoprosthesis
Manufacturer: W. L. Gore & Associates Inc.
Category: Medical Device — Vascular Endoprosthesis
Hazard: component-separation
Affected units: 255,861

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)

-Catalog numbers PLC*
PLA*
PLL*
RLT23*
RLT26*
RLT28*
RLT31*
RLT35*
HGB*
RLT231214X*
RLT231216X*
RLT231218X*
RLT231412X*
RLT231414X*
RLT231416X*
RLT231418X*
RLT261212X*
RLT261214X*
RLT261216X*
RLT261218X*

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 →

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

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High
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High
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Same hazard · component separation