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GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is inten...

FDA Device Recall #Z-0048-2018 — Class II — September 25, 2017

Recall Summary

Recall Number Z-0048-2018
Classification Class II — Moderate risk
Date Initiated September 25, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm W L Gore & Associates, Inc.
Location Flagstaff, AZ
Product Type Devices
Quantity 12,197units

Product Description

GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.

Reason for Recall

Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.

Distribution Pattern

Worldwide.

Lot / Code Information

Serial Numbers: TGE212110 TGE212110 TGE212110K TGU212110 TGU212110H TGU212110B TGU212110J TGE262610 TGE262610 TGE262610K TGU262610 TGU262610H TGU262610B TGU262610J TGE282810 TGE282810 TGE282810K TGU282810 TGU282810H TGU282810B TGU282810J TGE282815 TGE282815 TGE282815K TGU282815 TGU282815H TGU282815B TGU282815J TGE313110 TGE313110 TGE313110K TGU313110 TGU313110H TGU313110B TGU313110J TGE313115 TGE313115 TGE313115K TGU313115 TGU313115H TGU313115B TGU313115J TGE343410 TGE343410 TGE343410K TGU343410 TGU343410H TGU343410B TGU343410J TGE343415 TGE343415 TGE343415K TGU343415 TGU343415H TGU343415B TGU343415J TGE343420 TGE343420 TGE343420K TGU343420 TGU343420H TGU343420B TGU343420J TGE373710 TGE373710 TGE373710K TGU373710 TGU373710H TGU373710B TGU373710J TGE373715 TGE373715 TGE373715K TGU373715 TGU373715H TGU373715B TGU373715J TGE373720 TGE373720 TGE373720K TGU373720 TGU373720H TGU373720B TGU373720J TGE404010 TGE404010 TGE404010K TGU404010 TGU404010H TGU404010B TGU404010J TGE404015 TGE404015 TGE404015K TGU404015 TGU404015H TGU404015B TGU404015J TGE404020 TGE404020 TGE404020K TGU404020 TGU404020H TGU404020B TGU404020J TGE454510 TGE454510 TGE454510K TGU454510 TGU454510H TGU454510B TGU454510J TGE454515 TGE454515 TGE454515K TGU454515 TGU454515H TGU454515B TGU454515J TGE454520 TGE454520 TGE454520K TGU454520 TGU454520H TGU454520B TGU454520J TGE262110 TGE262110 TGE262110K TGU262110 TGU262110H TGU262110B TGU262110J TGE312610 TGE312610 TGE312610K TGU312610 TGU312610H TGU312610B TGU312610J TGU212115J TGU212120J TGU262615J TGU262620J TGU282820J TGU313120J

Other Recalls from W L Gore & Associates, Inc.

Recall # Classification Product Date
Z-0036-2026 Class II GORE ACUSEAL Vascular Graft, REF: ECH050020J, E... Aug 26, 2025
Z-2946-2024 Class II Heparin, Gore Viabahn VBX, Balloon Expandable E... Jul 1, 2024
Z-2945-2024 Class II Heparin, Gore Viabahn VBX, Balloon Expandable E... Jul 1, 2024
Z-1048-2023 Class II GORE CARDIOFORM Septal Occluder, REF: GSX0030A Dec 14, 2022
Z-0136-2023 Class II GORE CARDIOFORM ASD Occluder. cardiovascular im... Sep 21, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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