CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report

Gore¿ Excluder¿ Iliac Branch Endoprosthesis (Ibe) recalled

W. L. Gore & Associates is recalling Gore¿ Excluder¿ Iliac Branch Endoprosthesis (Ibe). The recall was initiated on 6 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes-Catalog numbers PLC*, PLA*, PLL*, RLT23*, RLT26*, RLT28*, RLT31*, RLT35*, HGB*, and CEB* *= size -not specific to any particular lot or serial numbers. For full details of affected products see 806 Attachment 1 - Catalog Numbers and Sizes.

Quantity recalled23212 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0996-2020
FDA event ID: 84533
Recalling firm: W. L. Gore & Associates, Phoenix, AZ
Classification: Class II
Status: Terminated
Recall initiated: 6 Jan 2020
FDA classified: 4 Feb 2020
Reported: 12 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Jan 2020	Recall initiated by company
4 Feb 2020	Classified by FDA	+29 days
12 Feb 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Firm has received reports of leading end catheter component separations.

Product as listed by the FDA

GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)

Where it was distributed

US: OUS: Australia; Austria; Canada; China; Taiwan; United Arab Emirates; Argentina; Brazil; Switzerland; Chile; Colombia; Costa Rica; Czechia; Spain; Greece; Croatia; Hungary; Ireland; Israel; Italy; United Kingdom; Lebanon; Mexico; New Zealand; Panama; Poland; Saudi Arabia; Slovenia; Germany; Netherlands; Norway; Finland; France; Sweden; Monaco;

Questions about this recall

Why was it recalled?

Firm has received reports of leading end catheter component separations.

Which lots are affected?

-Catalog numbers PLC*, PLA*, PLL*, RLT23*, RLT26*, RLT28*, RLT31*, RLT35*, HGB*, and CEB* *= size -not specific to any particular lot or serial numbers. For full details of affected products see 806 Attachment 1 - Catalog Numbers and Sizes.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 84533

This product is part of a recall event; the main page for the event is Gore¿ Excluder¿ Aaa Endoprosthesis recalled by W. L. Gore & Associates.

Reported	Class	Recall	Company	Reason	Where
12 Feb 2020	CLASS II	Gore¿ Excluder¿ Aaa Endoprosthesis recalled by W. L. Gore & Associates	W. L. Gore & Associates	Other	AZ

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