Supera™ S-70-030-120-P6Recalls & reported problems
Abbott Vascular Inc. · Supera™ Peripheral Stent System 7.0 mm x 30 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648344244), received between Apr 22, 2025 and Apr 22, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Activation 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Failure1
- Difficult to Remove1
- Improper or Incorrect Procedure or Method1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Activation Failure; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Activation Failure
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT COMMON FEMORAL ARTERY WITH A 7MM VESSEL DIAMETER. AFTER THE LESION WAS PRE-DILATED WITH A 6.0X40MM ARMADA 18 BALLOON DILATATION CATHETER (BDC) AN ATHERECTOMY WAS PERFORMED WITH A NON-ABBOTT DEVICE. A 7.0X30MM SUPERA SELF-EXPANDING STENT (SES) WAS ADVANCED THROUGH A 6F NON-ABBOTT SHEATH; AND DEPLOYED 4 TO 5CM FROM THE DISTAL END OF THE SHEATH, AND UNDER FLUOROSCOPY THE STENT APPEARED TO BE FULLY DEPLOYED. FOLLOWING THIS, THE THUMBSLIDE WAS FULLY RETRACTED AND, WITH THE DEPLOYMENT LEVER STILL IN THE OPEN POSITION, THE DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED; HOWEVER, RESISTANCE WITH THE GUIDEWIRE WAS FELT, AND THE TIP OF THE SES WAS NOTED TO SEPARATE. AN ATTEMPT TO CAPTURE THE SEPARATED TIP WITH THE SHEATH WAS MADE, BUT THE TIP WAS NOTED TO DISLODGE FROM INSIDE THE SHEATH BUT WAS STILL OVER THE GUIDEWIRE IN USE. THEREFORE, A HEMOSTAT WAS USED TO RETRIEVE THE SEPARATED TIP, AND AT THIS POINT, THE STENT WAS NOTED TO BE REMOVED AS WELL AND LOCATED INSIDE THE INTRODUCER SHEATH. FINALLY, AS A REMEDIAL MEASURE ANOTHER SUPERA SES WAS DEPLOYED TO TREAT THE LESION AND THE PROCEDURE WAS COM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21882043 ↗
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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