The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0291-2022·Announced 2021-12-01

Medtronic Endurant II Stent Graft Systems Recalled Due to Potential Spindle Detachment

Medtronic is recalling 511 Endurant II Stent Graft Systems because during deployment, the spindle may detach from the distal end of the spindle hypotube.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II classification indicates a serious device defect. The potential spindle detachment during stent graft deployment represents a risk-of-harm scenario for a critical vascular surgical device. No injuries or deaths have been reported in the source material.

Plain-English summary

Medtronic Vascular, Inc. is recalling 511 Endurant II Stent Graft Systems distributed worldwide. The recall is due to a potential hazard during stent graft deployment: the spindle may detach from the distal end of the spindle hypotube.

In the United States, affected devices were distributed in California, Florida, Georgia, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and West Virginia. Internationally, devices were distributed to Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, Switzerland, and the United Kingdom.

The Endurant II Stent Graft System is available in multiple configurations. Affected units are identified by specific model numbers and serial numbers provided in the recall documentation.

The recalled product

Product
Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF…
Manufacturer
Medtronic Vascular, Inc.
Category
Medical Device — Vascular Stent Graft
Hazard
Affected units
511

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Medtronic Vascular, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Medtronic Vascular, Inc.

See all →

Same hazard · device malfunction

See all →

Similar recalls