FDA Device recall Z-0996-2020
GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE) by W L Gore And Associates, citing firm has received reports of leading end catheter component separations.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0996-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-06 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | W L Gore And Associates |
| Distribution | n/a |
Product
GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
Reason
Firm has received reports of leading end catheter component separations.
Identifiers
| code_info | -Catalog numbers PLC*, PLA*, PLL*, RLT23*, RLT26*, RLT28*, RLT31*, RLT35*, HGB*, and CEB* *= size -not specific to…-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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0996-2020%22
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