Z-0290-2021Class II

GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System

Name: Z-0290-2021 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

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 "Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0290-2021
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: Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible
FDA root cause: Unknown/Undetermined by firm
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 inability to complete secondary deployment and that the Recalling Firm will be updating it Instruction for Use to include a new Warning: Secondary deployment events have occurred where the device does not open to full diameter after Secondary Deployment Handle actuation, and the deployment line is not accessible via the Deployment Line Access Hatch. If this event occurs, Gore recommends using the GORE Tri-Lobe Balloon Catheter to expand the device from trailing end to leading end after complete delivery system component removal. (Please refer to the GORE Tri-Lobe Balloon Catheter Instructions for Use for pertinent recommended volume, directions and warnings.) Ballooning of a non-fully expanded stent graft may lead to improper placement of the stent graft and/or branch vessel occlusion or obstruction. Use of an occlusion balloon may lead to device distal displacement during deployment (windsock effect) and has been observed to lead to branch vessel occlusion or obstruction. Customers are instructed to: -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 Thoracic Stent Graft System. The Recalling Firm maintains its confidence in the safety and efficacy of the device and is not 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
Quantity in commerce: 13860 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-0290-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0290-2021	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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)