Z-1976-2021Class II

Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular...

Name: Z-1976-2021 Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular...
Creator: Medtronic Vascular, Inc.
Published: 2021-04-28
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-04-28 / Terminated / root cause: manufacturing process

FDA source

Medtronic Vascular, Inc. began a recall of Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms on 2021-04-28. FDA classified it as Class II and gives the reason as "Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1976-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-28
Posted: 2021-06-28
Terminated: 2024-04-05
Recalling firm: Medtronic, Inc.
Product: Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Beginning on 04/28/2021, the Recalling Firm initiated a verbal notification and retrieved affected product for a single U.S. customer. On 05/10/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via UPS 2-day delivery to inform its impacted customer that the Recalling Firm has determined that the stent graft system was manufactured with an incorrect stentstop assembly. The letter was also to to ask for confirmation that the customer no longer had the affected devices in its possession. The letter instructed customers to take the following actions: 1. Complete the enclosed Customer Confirmation Form and email to [email protected]. 2. Forward this notice to all those who need to be aware within your organization. If there are any questions - contact the Recalling Firm's Field Representative.
Quantity in commerce: 3 devices
Distribution: U.S. Nationwide distribution in the state of GA. O.U.S.: None
Product codes and lots: Model Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787; V30064789; V30064790;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1976-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1976-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-28

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)