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.
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 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 ETBF2820C166
- Manufacturer
- Medtronic Vascular, Inc.
- Hazard
- device-malfunction
- spindle-detachment
Distribution
Distributed nationwide across the United States.
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