Medtronic Vascular, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1976-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 28, 2021

Date Posted: July 7, 2021

Recall Number: Z-1976-2021

Event ID: 88028

Reason for Recall:

Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.

Status: Terminated

Product Quantity: 3 devices

Code Information:

Model Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787; V30064789; V30064790;

Distribution Pattern:

U.S. Nationwide distribution in the state of GA. O.U.S.: None

Voluntary or Mandated:

Voluntary: Firm initiated