SUPERA S-60-030-120-P6Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648211881), received between Aug 30, 2016 and Dec 30, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT THE LEFT ANTERIOR TIBIAL ARTERY. THE RATCHET [THUMBSLIDE] WAS NOT CATCHING THE DEVICE AND DIFFICULTY WAS NOTED DURING DEPLOYMENT OF THE 6.0X30MM SUPERA SELF-EXPANDING STENT OVER A 0.018 GUIDEWIRE. AFTER MANIPULATION WITH THE CATHETER, THE SES WAS ABLE TO FULLY DEPLOY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23928774 ↗
• MalfunctionFeb 4, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-CALCIFIED, MILDLY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. PRE-DILATATION WAS DONE WITH A 6.0X40MM ARMADA 18 BALLOON INFLATED TO NOMINAL AT 8ATM FOR 2 MINUTES. THE 6.0X30MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED USING A 6F SHEATH (55CM), UP AND OVER THE ILIAC, WITH NO RESISTANCE. THEN UPON DEPLOYMENT, IT WAS OBSERVED UNDER FLUOROSCOPY THAT THE NOSE CONE WAS STARTING TO BECOME DETACHED. THEREFORE, THE PHYSICIAN QUICKLY FINISHED DEPLOYING THE STENT AND A DECISION WAS MADE TO RETRACT THE THUMB SLIDE BACK TO REMOVE THE SYSTEM WITH THE GUIDEWIRE AS A SINGLE UNIT. AFTER THE DEVICES WERE SUCCESSFULLY REMOVED FROM THE PATIENT, THE PHYSICIAN PULLED ON THE NOSE CONE AND IT BECAME EASILY FULLY DETACHED. THE TARGET LESION WAS TREATED. THE PATIENT IS STABLE. NO OTHER ISSUES NOTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11280237 ↗
• InjuryAug 30, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016 THREE SUPERA STENTS WERE DEPLOYED IN THE SUPERFICIAL FEMORAL ARTERY. DUE TO RESTENOSIS OBSERVED IN THE PREVIOUSLY TREATED AREA, THE PATIENT UNDERWENT REVASCULARIZATION ON (B)(6) 2016. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 5914943 ↗