SUPERA S-65-100-120-P6 (UDI 08975370026375)Recalls & reported problems
Abbott Vascular Inc. · Supera Peripheral Stent System 6.5 mm x 100 mm x 120 cm 6 F · Class 3 · Implant
All models of SUPERA (55)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08975370026375), received between Nov 11, 2016 and Nov 11, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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 16, 2026.
Most reported problems
Device problems
- Positioning Failure1
- Stretched1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2016Positioning Failure; Stretched
IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON FEMORAL ARTERY. THE VESSEL DIAMETER WAS 6.5 MM. A 6FR INTRODUCER SHEATH WAS USED FOR ACCESS. ATHERECTOMY WAS USED. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 6.0MM NON-ABBOTT BALLOON DILATATION CATHETER. THE 6.5 X 100 MM SUPERA SELF-EXPANDING STENT (SESS) WAS ADVANCED IN THE PATIENT ANATOMY, HOWEVER DURING DEPLOYMENT THE STENT ELONGATED; PARTIALLY DEPLOYED INSIDE THE PATIENT AND PARTIALLY INSIDE THE SHEATH. THE SESS WAS REMOVED ALONG WITH THE PARTIALLY EXPANDED STENT, WITHOUT ISSUE. THERE WAS NO RESISTANCE DURING DEPLOYMENT OR DURING REMOVAL. THE PROCEDURE WAS ABORTED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6095632 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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