SUPERA S-65-120-120-P6 (UDI 08975370026382)Recalls & reported problems
Abbott Vascular Inc. · Supera Peripheral Stent System 6.5 mm x 120 mm x 120 cm 6 F · Class 3 · Implant
All models of SUPERA (55)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08975370026382), received between Nov 3, 2016 and Jan 26, 2017 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
- Positioning Failure1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 26, 2017Positioning Failure
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.5 X 120 SUPERA STENT WAS BEING DEPLOYED WHEN THE GUIDE WIRE KINKED AND THE SHEATH MOVED FORWARD AND PART OF THE STENT WAS DEPLOYED IN THE SHEATH. THE DEVICES COULD NOT BE REMOVED SO THE PATIENT WAS SENT TO SURGERY WHERE A CUTDOWN WAS PERFORMED TO REMOVE THE DEVICES THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT IS IN GOOD CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6280413 ↗InjuryNov 3, 2016Detachment Of Device Component
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 6.5X120MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITHOUT RESISTANCE TOWARD THE TARGET LESION AND THE STENT WAS DEPLOYED. USING FLUORO, THE DELIVERY CATHETER WAS REMOVED WITHOUT RESISTANCE AND THE CATHETER TIP SEPARATED AND REMAINED IN THE PATIENT ANATOMY. A SNARE DEVICE WAS USED TO SUCCESSFULLY RETRIEVE THE CATHETER TIP FROM THE PATIENT ANATOMY. THE THUMB SLIDE WAS FULLY RETRACTED TO THE START POSITION AND BOTH THE SYSTEM AND DEPLOYMENT LEVERS WERE LOCKED PRIOR TO REMOVAL. THERE WAS A DELAY IN THE PROCEDURE BUT THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6077629 ↗
Other STENT, SUPERFICIAL FEMORAL ARTERY devices
- EverFlex™ EVD35-06-150-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 death110 reports
- SUPERA S-60-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY108 reports
- SUPERA S-55-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY88 reports
- LifeStent® Solo Vascular Stent EX062003CLBard Peripheral Vascular, Inc. · STENT, SUPERFICIAL FEMORAL ARTERY80 reports
- BioMimics 3D Vascular Stent System 144700-12Veryan Medical Limited · Stent, Superficial Femoral Artery74 reports
- SUPERA S-50-120-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY55 reports
- EverFlex™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
- EverFlex™ EVD35-07-120-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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