SUPERA S-45-120-120-P6 (UDI 08717648226007)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648226007), received between Apr 3, 2019 and Aug 20, 2026 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50359521 ↗
• MalfunctionMar 2, 2026Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE POPLITEAL ARTERY. THE 4.50 X 120 MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING DEPLOYMENT THE STENT ONLY PARTIALLY DEPLOYED. THE SES WITH THE STENT WAS REMOVED WITHOUT ISSUE. ANOTHER SUPERA WAS USED TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 24487104 ↗
• MalfunctionJan 29, 2026Difficult or Delayed Activation

  IT WAS REPORTED WAS THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED DE NOVO LESION IN THE POPLITEAL ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 4.5X120MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND THE THUMBSLIDE WAS PUSHED AND THE STENT WAS RELEASED; HOWEVER, THE STENT FAILED TO DETACH FROM THE DELIVERY SYSTEM. THE THUMBSLIDE WAS MOVED MULTIPLE TIMES AND THE SYSTEM RELOCKED AND UNLOCKED. ULTIMATELY, THE STENT WAS DETACHED BY GENTLY SHAKING THE DELIVERY SYSTEM. THE STENT WAS IMPLANTED TO TREAT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211816 ↗
• MalfunctionJan 6, 2026Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE 4.50X120MM SUPERA SELF EXPANDING STENT SYSTEM (SES), IT WAS NOTED THE TIP WAS SEPARATED; THEREFORE, THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973033 ↗
• MalfunctionJun 24, 2025Stretched; Difficult to Advance; Activation Failure; Stretched; Difficult to Advance; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 4.50X120MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED. DEPLOYMENT WAS ATTEMPTED HOWEVER THE STENT PARTIALLY DEPLOYED IN THE INTRODUCER SHEATH AND ELONGATED. THE SES WITH THE PARTIALLY DEPLOYED ELONGATED STENT WAS REMOVED AND THE PROCEDURE COMPLETED USING ANOTHER SUPERA. 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 22318773 ↗
• MalfunctionJun 12, 2025Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, SUPERFICIAL FEMORAL ARTERY THAT IS 90% STENOSED. THE VESSEL WAS PREPPED WITH AN UNSPECIFIED BALLOON. THE 4.5X120MM SUPERA SELF-EXPANDING STENT WAS ATTEMPTED TO BE DEPLOYED, COULD NOT BE PUSHED OUT OF THE DELIVERY SHEATH, AND ONLY PARTIALLY DEPLOYED AS THERE WAS RESISTANCE WITH THE THUMBSLIDE. THE SUPERA WAS REMOVED UNDER FLUOROSCOPY. AN UNSPECIFIED STENT WAS USED TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22197047 ↗
• InjuryOct 30, 2023Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A GUIDE WIRE WAS ADVANCED AND PRE-DILATATION WAS PERFORMED WITH A BALLOON. THE 4.5X120MM SUPER SELF-EXPANDING STENT SYSTEM (SESS) WAS IMPLANTED. HOWEVER, THROMBUS WAS GENERATED IN THE TARGET VESSEL DUE TO POOR ADHERENCE TO THE WALL AND THE STENT WAS DISPLACED TO THE DISTAL END. A SNARE DEVICE WAS USED TO REMOVE THE STENT IMMEDIATELY AND THE CLOT SUBSEQUENTLY DISAPPEARED ON ITS OWN WITHOUT SURGICAL INTERVENTION. ANOTHER 5.5MM SUPERA STENT WAS IMPLANTED AND COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELAE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18029941 ↗
• MalfunctionApr 4, 2023Difficult to Remove; Improper or Incorrect Procedure or Method; Activation Failure; Difficult to Remove; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. AFTER PRE DILATING THE 4.2MM VESSEL WITH A NON-ABBOTT BALLOON AT 6 ATMOSPHERES (ATM) FOR THREE MINUTES. THE 4.5X120 SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE DEPLOYMENT LOCK WAS STILL LOCKED. THE DEPLOYMENT LOCK WAS THEN UNLOCKED AND THE THUMBWHEEL WAS BEING SLIDE BUT THE STENT STOPPED DEPLOYING AFTER ONE- THIRD (PARTIALLY). THE DELIVERY SYSTEM WAS FORCIBLY REMOVED UNDER FLUOROSCOPY. ANOTHER 4.5X120 SUPERA STENT WAS USED TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16678692 ↗
• MalfunctionNov 26, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MODERATELY CALCIFIED AND MODERATELY TORTUOUS VESSEL IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMETER WAS 4.5MM AND ATHERECTOMY WAS NOT USED IN THE PROCEDURE. PRE-DILATATION WAS PERFORMED USING A 5MMX120MM BALLOON WITH A PRESSURE OF 8 ATMOSPHERES (ATMS) FOR 5MIN. THE 4.5X120MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO BE RELEASED BUT COULD NOT BE SEPARATED FROM THE DELIVERY SHEATH. THE STENT AND THE DELIVERY SHEATH WERE WITHDRAWN TOGETHER FROM THE ANATOMY UNDER FLUOROSCOPY. ANOTHER SUPERA SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12878257 ↗
• InjuryMar 23, 2021Material Separation; Difficult or Delayed Activation; Material Separation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE SUPERA STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION AND STENT DEPLOYMENT WAS INITIATED. WHEN ABOUT HALF OF THE STENT WAS DEPLOYED, RESISTANCE WAS NOTED, DUE TO THE PATIENT ANATOMY. THE STENT DELIVERY SYSTEM WAS PULLED BACK SLIGHTLY AND IT WAS NOTED THAT THE DELIVERY SYSTEM CATHETER NOSE CONE DETACHED. STENT DEPLOYMENT CONTINUED; HOWEVER, DUE TO THE ISSUES, THE STENT DID NOT FULLY COVER THE TARGET LESION. AFTER THE STENT WAS DEPLOYED AND THE STENT DELIVERY SYSTEM WAS REMOVED, AN ATTEMPT WAS MADE TO RETRIEVE THE SEPARATED NOSE CONE; HOWEVER, THE NOSE CONE WAS UNABLE TO BE RETRIEVED. THE NOSE CONE EMBOLIZED TO THE SFA AND REMAINS IN THE PATIENT ANATOMY. A SECOND SUPERA STENT DELIVERY SYSTEM WAS IMPLANTED TO TREAT THE REMAINING LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11554976 ↗
• MalfunctionMar 17, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT POPLITEAL ARTERY. A 4.5X120MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION. AFTER DEPLOYING THE STENT, THE PHYSICIAN PULLED BACK THE DELIVERY SYSTEM AND THE STENT PULLED BACK INTO THE 6 FRENCH SHEATH. BOTH WERE REMOVED FROM THE ANATOMY AND ANOTHER SUPERA WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9842803 ↗
• MalfunctionMar 4, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISTAL SUPERFICIAL FEMORAL AND POPLITEAL ARTERY. AFTER DEPLOYMENT OF A 4.5X120MM SUPERA STENT, AND DURING REMOVAL OF THE DELIVERY SYSTEM IT WAS NOTED THAT THE TIP WAS MISSING. THE PHYSICIAN WAS ABLE TO PULL BACK THE ENTIRE DELIVERY SYSTEM INTO THE SHEATH, INCLUDING THE STENT IMPLANT AND SEPARATED TIP AND REMOVE THE WHOLE UNIT ALTOGETHER. THERE WAS NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9788677 ↗
• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT POPLITEAL ARTERY. ON (B)(6) 2019, A SUPERA STENT WAS IMPLANTED; HOWEVER, ON (B)(6) 2019, REVASCULARIZATION WAS PERFORMED AS THE LESION BECAME RESTENOSED AND THE PATIENT PRESENTED WITH A NON-HEALING GANGRENE WOUND. THEREFORE, BALLOON ANGIOPLASTY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis; Unspecified Infection

  MAUDE report 8540010 ↗
• MalfunctionApr 3, 2019Material Separation; Stretched; Deformation Due to Compressive Stress; Difficult to Advance; Material Separation; Stretched; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE 4.5X120 MM SUPERA STENT DELIVERY SYSTEM (SDS) WAS LOADED ON THE GUIDE WIRE, BUT IT COULD NOT BE ADVANCED INTO THE BODY. THE SDS WAS REMOVED FROM THE GUIDE WIRE AND THE GUIDE WIRE WAS WIPED DOWN. THEY RELOADED THE SDS ON TO THE SAME GUIDE WIRE, BUT STILL COULD NOT ADVANCE IT. IT WAS THEN NOTED THAT THE DISTAL END OF THE SDS WAS UNRAVELED. THE SDS WAS AGAIN REMOVED FROM THE GUIDE WIRE. A 5.5 MM SUPERA WAS PREPARED AND WAS ABLE TO ADVANCE OVER THE SAME GUIDE WIRE WITHOUT FURTHER INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DEVICE ANALYSIS FOUND THAT THE TIP OF THE SDS HAD SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8479421 ↗