CLASS II Device recall · Reported 27 May 2020 · FDA Enforcement Report
Conformable Thoracic Stent Graft recalled by W L Gore & Associates
W L Gore & Associates is recalling Conformable Thoracic Stent Graft. The recall was initiated on 17 Dec 2019 and the FDA has classified it as Class II.
Check your package
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-2052-2020
- FDA event ID
- 85434
- Recalling firm
- W L Gore & Associates, Flagstaff, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2019
- FDA classified
- 20 May 2020
- Reported
- 27 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 17 Dec 2019 | Recall initiated by company | |
| 20 May 2020 | Classified by FDA | +155 days |
| 27 May 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The incorrect label was placed on both the primary and secondary package.
Product as listed by the FDA
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
Where it was distributed
International the country of Japan.
Questions about this recall
Why was it recalled?
The incorrect label was placed on both the primary and secondary package.
Which lots are affected?
Part number of the device is TGM343420J Serial numbers: 21225065 21225066 21225067 21225068 21225069 21225070 21225071 21225072 21225073 21225074 21225075 21225076 21225077 21225078 21225079 21225080 21225081 21225082 21225083 21225084
Where was it sold?
International the country of Japan.
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.
More recalls from W L Gore & Associates
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The Gore Viabil Short Wire Biliary Endoprosthesis recalled | W L Gore & Associates | Labeling Errors | Nationwide |
| Device | CLASS II | Gore Viabil Short Wire Biliary Endoprosthesis recalled | W L Gore & Associates | Labeling Errors | Nationwide |
| Device | CLASS II | Gore Viabil Short Wire Biliary Endoprosthesis recalled | W L Gore & Associates | Labeling Errors | Nationwide |
| Device | CLASS II | GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component recalled | W L Gore & Associates | Other | Nationwide |
| Device | CLASS II | Gore Acuseal Vascular Graft recalled by W L Gore & Associates | W L Gore & Associates | Packaging Defects | 51 states |
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