The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0290-2022·Announced 2021-12-01

Endurant Stent Graft System spindle detachment during deployment

Medtronic recalls 2 Endurant Stent Graft System devices due to potential spindle detachment from the hypotube during surgical deployment. The mechanical failure could affect graft positioning.

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 device with a documented mechanical failure mode (spindle detachment) occurring during a critical surgical procedure. No adverse events are reported in the source text, and the hazard is deployment-related, placing this in the High category rather than Severe.

Plain-English summary

Medtronic Vascular, Inc. is recalling 2 Endurant Stent Graft System devices (Model ENTF2525C70EE, Serial Numbers V30624638 and V30624639). These devices have been distributed worldwide and in the United States to California, Florida, Georgia, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and West Virginia.

During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube. This mechanical failure could occur during the surgical procedure and compromise proper placement of the stent graft.

Healthcare facilities and physicians should immediately cease use of the affected serial numbers and contact Medtronic Vascular, Inc. for instructions regarding device return, replacement, or other corrective measures. Patients who have received implants with these serial numbers should consult with their implanting physician regarding appropriate clinical follow-up.

The recalled product

Product
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Manufacturer
Medtronic Vascular, Inc.
Category
Medical Device — Vascular / Stent Graft
Hazard
Affected units
2

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 →

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