Z-0291-2021Class II

GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

Name: Z-0291-2021 GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Creator: W L Gore & Associates, Inc.
Published: 2020-09-09
License: https://open.fda.gov/license/

W. L. Gore & Associates, Inc. / initiated 2020-09-09 / Open, Classified / root cause: manufacturing process

FDA source

W L Gore & Associates, Inc. began a recall of GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System on 2020-09-09. FDA classified it as Class II and gives the reason as "When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0291-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-09-09
Posted: 2020-10-23
Recalling firm: W. L. Gore & Associates, Inc.
Product: GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 09/23/2020, the firm sent an "URGENT Medical Device Safety Correction" via First Class Postal (USPS) informing them that all lots of its Thoracic Stent Graft Systems may encounter difficulty withdrawing the delivery catheter due to a proximal stent apex being lodged with the delivery catheter leading olive. Customers are instructed to: Immediate Actions for the Recipient: - Take note of amendment/reinforcement of Instructions For Use (IFU) - Please respond to the enclosed acknowledgement - Please share this letter with others in your hospital or clinic as appropriate The Recalling Firm is providing physicians with this information so that appropriate risk-related decisions can be made with the patient when considering the Conformable Thoracic Stent Graft System. The Recalling Firm maintains its confidence in the safety and efficacy of the device and will not be removing the affected products from the market. There are no actions required for patients already implanted with the Thoracic Stent Graft. Please contact the Recalling Firm's Customer Service (email: [email protected] or by phone at 800-528-8763) with any questions related to this letter.
Quantity in commerce: 19013 units
Distribution: U.S. - Nationwide O.U.S. - Australia, Austria, Belgium, Croatia, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Monaco, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom
Product codes and lots: CATALOG NUMBERS TGM212110X* TGM212115X* TGM212120X* TGM262610X* TGM262615X* TGM262620X* TGM282810X* TGM282815X* TGM282820X* TGM313110X* TGM313115X* TGM313120X* TGM343410X* TGM343415X* TGM343420X* TGM373710X* TGM373715X* TGM373720X* TGM404010X* TGM404015X* TGM404020X* TGM454510X* TGM454515X* TGM454520X* TGM262110X* TGM312610X* TGMR313110X* TGMR313115X* TGMR313120X* TGMR312610X* TGMR373710X* TGMR373715X* TGMR373720X* TGMR404010X* TGMR404015X* TGMR404020X* *X is a placeholder for enumeration code: E=EMEA, Australia, New Zealand; J=Japan All Lot Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0291-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0291-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-04	2020-10-23

Product code MIH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)