FDA Device recall Z-0995-2020
GORE¿ EXCLUDER¿ AAA Endoprosthesis
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of GORE¿ EXCLUDER¿ AAA Endoprosthesis 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-0995-2020 |
| 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¿ AAA Endoprosthesis
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 Table 1: Device C…-Catalog numbers PLC*, PLA*, PLL*, RLT23*, RLT26*, RLT28*, RLT31*, RLT35*, HGB*, and CEB* *= size Table 1: Device Configurations for Trunk-Ipsilateral Leg Component: RLT231212X*; RLT231214X*; RLT231216X*; RLT231218X*; RLT231412X*; RLT231414X*; RLT231416X*; RLT231418X*; RLT261212X*; RLT261214X*; RLT261216X*; RLT261218X*; RLT261412X*; RLT261414X*, RLT261416X*; RLT261418X*; RLT281212X*; RLT281214X*; RLT281216X*; RLT281218X*; RLT281412X*; RLT281414X*; RLT281416X*; RLT281418X*; RLT311413X*; RLT311415X*; RLT311417X*; RLT351414X*; RLT351416X*; RLT351418X*; Table 2: Discontinued Device Configurations for Trunk-Ipsilateral Leg Component: RMT231212X*; RMT231214X*; RMT231216X*; RMT231218X*; RMT231412X*; RMT231414X*; RMT231416X*; RMT231418X*; RMT261212X*; RMT261214X*; RMT261216X*; RMT261218X*; RMT261412X*; RMT261414X*; RMT261416X*; RMT261418X*; RMT281212X*; RMT281214X*; RMT281216X*; RMT281218X*; RMT281412X*; RMT281414X*; RMT281416X*; RMT281418X*; RMT311413X*; RMT311415X*; RMT31141 |
|---|
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-0995-2020%22
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