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.
What this means for you
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.
- Hazard
- device-malfunction
- deployment-failure
Distribution
Distributed nationwide across the United States.
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