SUPERA S-65-120-120-P6 (UDI 08717648226304)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648226304), received between Sep 26, 2018 and Aug 5, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Difficult to Remove; Material Twisted/Bent; Activation Failure

  Subsequent to the initial report being filed, it was reported that during removal of the 6.5x120mm Supera self-expanding stent system (SESS), the partially deployed stent became fully deployed while inside the introducer sheath. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50145144 ↗
• MalfunctionJul 17, 2026Stretched

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25857099 ↗
• InjuryMar 17, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE POPLITEAL ARTERY. TWO STENT GRAFTS WERE IMPLANTED AND A 6.5X120MM SUPERA STENT WAS DEPLOYED; HOWEVER, WHEN ATTEMPTING TO REMOVE THE SUPERA DELIVERY SYSTEM THE TIP BECAME STUCK IN THE STENT GRAFT AND SEPARATED. IT WAS NOTED THAT THE DEPLOYMENT LEVERS WERE NOT LOCKED WHEN REMOVING THE DELIVERY SYSTEM. THE SEPARATED PORTION WAS REMOVED VIA SNARE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621336 ↗
• InjuryOct 10, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO A TREAT 50% STENOSED LESION IN THE SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES WITH CALCIFICATION. DURING USE OF THE 6.5X120MM SUPERA SELF EXPANDING STENT SYSTEM (SESS), THE NOSECONE BECAME SEPARATED. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF REMOVAL OF THE SESS. THE STENT WAS NOT IMPLANTED. A NON-ABBOTT FILTER WAS USED TO RETRIEVE THE NOSECONE FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17909390 ↗
• MalfunctionSep 23, 2020Break; Stretched; Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure; Break; Stretched; Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS DE NOVO LESION IN THE COMMON FEMORAL ARTERY (CFA) TO THE PROXIMAL SUPERIOR FEMORAL ARTERY (SFA). A 6.5X120MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION. DURING DEPLOYMENT, RESISTANCE WAS MET WITH THE THUMBSLIDE; THEREFORE, FORCE WAS APPLIED, AND THE STENT ELONGATED. AFTER APPROXIMATELY 30MM OF THE STENT WAS DEPLOYED, THE STENT COULD NOT BE DEPLOYED ANY FURTHER. TROUBLESHOOTING WAS PERFORMED; HOWEVER, UNSUCCESSFUL AND THE HANDLE BROKE. THE SESS, INCLUDING THE STENT, WAS REMOVED WITHOUT ISSUE. PRE-DILATATION WAS PERFORMED AGAIN AND TWO SUPERA STENTS WERE IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10577828 ↗
• MalfunctionApr 10, 2020Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN A DENSELY CALCIFIED LEFT POPLITEAL / DISTAL SUPERFICIAL FEMORAL ARTERY LESION. THE PATIENT HAD PREVIOUSLY IMPLANTED STENTS IN THE VESSEL AND A NEW AREA OF STENOSIS WAS NOTED DISTAL TO THE IMPLANTED STENTS. THE SUPERA STENT DELIVERY SYSTEM WAS ADVANCED THROUGH AN UNSPECIFIED 6 FRENCH SHEATH AND ADVANCED TO THE TARGET SITE WITHOUT ISSUE. DEPLOYMENT WAS INITIATED. AFTER THE STENT WAS PARTIALLY DEPLOYED, DEPLOYMENT STOPPED. THE THUMBSLIDE WAS ABLE TO ADVANCE WITHOUT RESISTANCE, BUT IT SEEMED AS IF THE RATCHET WAS NOT ENGAGING AND THE STENT WOULD NOT DEPLOY. THE PHYSICIAN TRIED ROTATING THE DELIVERY SYSTEM, IN AN ATTEMPT TO ENGAGE THE RATCHETS, BUT THE STENT WOULD NOT DEPLOY. THE DECISION WAS MADE TO REMOVE THE STENT, STENT DELIVERY SYSTEM AND GUIDE WIRE AS A SINGLE UNIT. NO ATTEMPT WAS MADE TO REMOVE THE STENT DELIVERY SYSTEM FROM THE GUIDE WIRE; THE PHYSICIAN CHOSE TO REMOVE ALL DEVICES AS A SINGLE UNIT TO PREVENT PATIENT INJURY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9950509 ↗
• InjuryMar 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. FOLLOWING PRE-DILATATION, A 6.5X120MM SUPERA SELF-EXPANDING STENT WAS DEPLOYED; HOWEVER, THE TIP SEPARATED. THE TIP WAS SUCCESSFULLY REMOVED WITH A SNARE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9776744 ↗
• InjuryNov 14, 2019Difficult to Remove; Material Separation; Activation Failure; Difficult to Remove; Material Separation; Activation Failure

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES, "PROCEDURE: LEFT LOWER EXTREMITY ANGIOGRAM, RECANALIZATION OF CHRONICALLY OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY, AND STENT PLACEMENT. DURING THIS DEPLOYMENT OF THE STENT, THE NOSE CONE OF THE DEPLOYMENT APPARATUS BECAME WEDGED IN THE TIP OF THE 6 FRENCH SHEATH AND DETACHED FROM THE REMAINDER OF THE DEPLOYMENT APPARATUS. IT WAS QUICKLY REALIZED THAT SOME OF THE STENT REMAINED UN-DEPLOYED WITHIN THE 6 FRENCH RIGHT GROIN SHEATH. FDA SAFETY REPORT ID# (B)(4)." ADDITIONAL INFORMATION PER THE MEDWATCH REPORT: EVENT OUTCOME REQUIRED INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9324956 ↗
• InjurySep 26, 2018Stretched; Difficult or Delayed Activation; Physical Resistance/Sticking; Stretched; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY/POPLITEAL ARTERY. PRE-DILATATION WAS PERFORMED AND THE SUPERA STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION. DEPLOYMENT WAS INITIATED AND THE THUMBSLIDE WAS ADVANCED. THE STENT BEGAN MOVING FORWARD; HOWEVER, THE PHYSICIAN COMMENTED THAT THE STENT DELIVERY SYSTEM ALSO SEEMED TO MOVE FORWARD. RESISTANCE WAS FELT WHEN ADVANCING THE THUMBSLIDE. THE STENT WAS DEPLOYED; HOWEVER, THE STENT ELONGATED APPROXIMATELY 3-4 CM. DUE TO THE LENGTH OF THE LESION, TWO STENTS WERE PLANNED. A SECOND SUPERA STENT, A 6.5 X 80 MM SUPERA, WAS DEPLOYED SO THAT IT OVERLAPPED THE ELONGATED STENT PORTION AND COVERED THE REMAINING LESION. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7912581 ↗