Z-2052-2020Class II

Conformable Thoracic Stent Graft, Rx only, Sterile EO -

Name: Z-2052-2020 Conformable Thoracic Stent Graft, Rx only, Sterile EO -
Creator: W L Gore & Associates, Inc.
Published: 2019-12-17
License: https://open.fda.gov/license/

W. L. Gore & Associates, Inc. / initiated 2019-12-17 / Terminated / root cause: labeling and UDI

FDA source

W L Gore & Associates, Inc. began a recall of Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic... on 2019-12-17. FDA classified it as Class II and gives the reason as "The incorrect label was placed on both the primary and secondary package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2052-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-17
Posted: 2020-05-20
Terminated: 2021-04-28
Recalling firm: W. L. Gore & Associates, Inc.
Product: Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: The incorrect label was placed on both the primary and secondary package.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 12/17/2019, the firm's field representatives hand delivered an URGENT MEDICAL DEVICE RECALL Notification to customers informing them of a label issue with their stents. Two (2) of the 20 units in their work order are labeled with the incorrect part number and size on both the package and carton labels. Customers are instructed to: return the affected products for replacement and If customers have any questions or concern to contact Field Sales Associates for assistance at Telephone number: 03-6746-2560, FAX number: 03-6746-2561
Quantity in commerce: 15 stents
Distribution: International the country of Japan.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2052-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2052-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-20

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)