SUPERA S-55-080-120-P6 (UDI 08717648226106)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648226106), received between Feb 20, 2019 and Feb 20, 2026 — classified as 5 injuries, 9 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.

• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. THE 5.50X80MM SUPERA SELF EXPANDING STENT WAS IMPLANTED. TWO DAYS POST PROCEDURE THE PATIENT RETURNED TO THE EMERGENCY ROOM WITH NO FLOW DOWN THE TREATED LEG. THROMBECTOMY WAS PERFORMED AND TISSUE PLASMINOGEN ACTIVATOR ADMINISTERED OVERNIGHT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24401524 ↗
• MalfunctionMay 14, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY WITH 90% BLOCKAGE AND MODERATE CALCIFICATION. THE AORTIC BIFURCATION WAS STEEP. THE VESSEL WAS PREPARED WITH A 7.0 MM BALLOON AT NOMINAL PRESSURE FOR 1 MINUTE. THE 5.5X80 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND THE STENT WAS DEPLOYED; HOWEVER THE STENT WOULD NOT RELEASE AND WAS REMOVED WITH THE DELIVERY SYSTEM AFTER DEPLOYMENT. A NEW SUPERA SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 22020597 ↗
• MalfunctionNov 3, 2021Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure; Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. PRE-DILATATION WAS PERFORMED WITH A 6MM BALLOON CATHETER AT 20 ATMOSPHERES FOR 60 SECONDS. A 5.5X80MM SUPERA STENT WAS ADVANCED TO THE LESION WITHOUT ISSUE AND DEPLOYMENT WAS INITIATED. IT WAS CONFIRMED THAT THE DEPLOYMENT LOCK WAS NOT UNLOCKED AND THE THUMB SLIDE WAS NOT ADVANCED TO THE MOST DISTAL POSITION ON THE HANDLE. DURING ATTEMPTED DEPLOYMENT, THE STENT COULD ONLY EMERGE 2CM FROM THE OUTER SHEATH, AS THE THUMBSLIDE COULD NOT ADVANCE FURTHER. THE DEVICE WAS SIMPLY REMOVED UNDER FLUOROSCOPY. A NON-ABBOTT STENT WAS USED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12745196 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A RESEARCH ARTICLE, IDENTIFYING THE SUPERA PERIPHERAL STENT SYSTEM AS FOLLOWS: IN (B)(6) 2019, PATIENT PRESENTED WITH BILATERAL INTERMITTENT CLAUDICATION (RUTHERFORD CLASSIFICATION. A 5.5X80MM AND A 6.0X80MM SUPERA SELF-EXPANDING STENT AND TWO NON-ABBOTT STENTS WERE IMPLANTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 5.5X120MM SUPERA STENT, ALONG WITH TWO NON-ABBOTT STENTS WERE IMPLANTED IN THE LEFT SUPERFICIAL FEMORAL ARTERIES, RESOLVING THE INTERMITTENT CLAUDICATION. SIX MONTHS AFTER STENT IMPLANTATION, THE PATIENT EXPERIENCED INTERMITTENT CLAUDICATION AND WAS HOSPITALIZED. IN-STENT RESTENOSIS (ISR) WAS OBSERVED AT THE SUPERA STENT SITES. BALLOON ANGIOPLASTY WAS PERFORMED AND STENTS WERE IMPLANTED RESOLVING THE RESTENOSIS AND CLAUDICATION. DETAILS ARE LISTED IN THE ARTICLE, TITLED CLINICAL PERFORMANCE OF POLYMER-COATED PACLITAXEL-ELUTING STENT IMPLANTED FOR DIFFUSE AND CALCIFIED SUPERFICIAL FEMORAL ARTERY STENOTIC LESIONS: INSIGHTS FROM A PATIENT ON HEMODIALYSIS.

  Patient problems: Pain; Stenosis

  MAUDE report 12277653 ↗
• InjuryJul 1, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT A 5.5X80MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED, AND THE STENT WAS PARTIALLY DEPLOYED. IN ORDER TO FULLY DEPLOY THE STENT, TWO ARMADA 14 (2.5X200 AND 3X200) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERS WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12101359 ↗
• MalfunctionJan 11, 2021Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT A 5.5X80MM SUPERA STENT MET RESISTANCE WHEN ATTEMPTING TO GO OVER THE UNSPECIFIED GUIDE WIRE. THE TIP SEPARATED DURING REMOVAL AS IT WAS NOTED RESISTANCE WAS MET AGAIN WITH THE UNSPECIFIED GUIDE WIRE. THE TIP WAS EASILY RECOVERED AS ACTUAL DEVICE DID NOT ENTER THE PATIENT'S ANATOMY; HOWEVER, THE UNSPECIFIED GUIDE WIRE WAS IN THE PATIENT'S ANATOMY DURING THE SUPERA'S ATTEMPT TO GO OVER THE GUIDE. ANOTHER SUPERA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11147469 ↗
• MalfunctionNov 16, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFICIAL FEMORAL ARTERY. A SUPERA STENT WAS ADVANCED TO THE LESION AND DEPLOYMENT WAS INITIATED, FOLLOWING THE INSTRUCTIONS FOR USE. HOWEVER, WHILE DEPLOYING, THE PHYSICIAN WAS UNABLE TO VISUALIZE THE STENT, AND DECIDED TO SIMPLY REMOVE THE DEVICE, ONLY HAVING IT PARTIALLY DEPLOYED (STILL REMAINING ON THE DELIVERY SYSTEM). THE LESION WAS ULTIMATELY BALLOONED, AND PROCEDURE COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS, AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10847345 ↗
• MalfunctionJul 1, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HIGHLY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. THE VESSEL DIAMETER WAS 5.5 MM AND THE VESSEL WAS PREPPED WITH A 5.5 MM ARMADA BALLOON. A 6FR 45 CM SHEATH WAS USED. THE SUPERA SELF EXPANDING STENT (SES) WAS DEPLOYED AND WHEN TAKING OUT THE DELIVERY CATHETER, THE STENT WAS STILL ATTACHED AND CAME OUT OF THE PATIENT WITH THE CATHETER. THERE WERE NO ISSUES REPORTED WITH THE DEPLOYMENT MECHANISM. A NEW SUPERA SES WAS DEPLOYED WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10218504 ↗
• MalfunctionJun 24, 2020Difficult to Remove; Material Separation; Activation Failure; Difficult to Remove; Material Separation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED AND MODERATELY CALCIFIED LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. A 6F X 45CM SHEATH WAS ADVANCED THROUGH THE 5.5MM VESSEL. THE VESSEL WAS PREPARED WITH ATHERECTOMY AND DILATATION WITH A 6.0X100MM ARMADA 18 BALLOON CATHETER FOR ONE MINUTE AT 8 ATMOSPHERES. DURING DEPLOYMENT OF A 5.5X80MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS), THE TIP OF THE SESS BECAME CAUGHT WITH THE STENT AND SEPARATED INSIDE THE SHEATH. WHEN REMOVING THE SESS FROM THE PATIENT THE STENT WAS PULLED BACK INTO THE SHEATH AS WELL. THE SHEATH WAS REMOVED AND THE CATHETER TIP AND STENT WERE BOTH REMOVED FROM THE PATIENT UNDER FLUOROSCOPY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BALLOON ANGIOPLASTY AND THE DEPLOYMENT OF AN UNSPECIFIED SUPERA STENT. 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 10189841 ↗
• MalfunctionJun 9, 2020Stretched; Difficult or Delayed Activation; Stretched; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 5.5X80MM SUPERA SELF-EXPANDING STENT SYSTEM WAS POSITIONED IN THE TARGET LESION. DURING DEPLOYMENT, THE THUMBSLIDE WAS ACTIVATED ALLOWING THE STENT TO ADVANCE BUT THE DEVICE FAILED TO RELEASE THE STENT. WHEN THE SHAFT WAS PULLED SLIGHTLY, THE STENT DEPLOYED AND ELONGATED FOR ABOUT 1CM AND EXTENDED TO THE BIFURCATION WITH THE DEEP FEMORAL ARTERY (DFA). THE STENT WAS DEPLOYED ACROSS THE BIFURCATION OF THE SFA AND DFA. 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 10132990 ↗
• MalfunctionJan 2, 2020Difficult to Remove; Material Separation; Stretched; Improper or Incorrect Procedure or Method; Activation Failure; Difficult to Remove; Material Separation; Stretched; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY THAT WAS 95 % RESTENOSED. A NON-ABBOTT GUIDE WIRE (GW) WAS ADVANCED TO THE LESION. PRE-DILATATION WAS PERFORMED WITH A 5X20MM UNSPECIFIED CUTTING BALLOON AND A 5X20MM NON-ABBOTT BALLOON AT 30 ATMOSPHERES. THEN IT WAS DECIDED TO CHANGE GW'S TO A COMMAND 18 GW. A 5.5X80MM SUPERA SELF-EXPANDING STENT WAS ADVANCED TO THE LESION AND ATTEMPTED TO DEPLOY BY SLIDING THE THUMBSLIDE, AND THOUGHT THE STENT HAD FULLY DEPLOYED. THEN THE DEPLOYMENT LOCK WAS ROTATED TO UNLOCK THE POSITION AND ADVANCE THE THUMBSLIDE TO THE MOST DISTAL POSITION. AFTERWARDS, THE THUMBSLIDE WAS RETRACTED TO THE STARTING POSITION AND ROTATED THE DEPLOYMENT LOCK/SYSTEM LOCK INTO LOCKED POSITION TO REMOVE THE DELIVERY SYSTEM. THE PHYSICIAN NOTED THAT RESISTANCE WAS FELT DURING REMOVAL OF THE SUPERA DELIVERY SYSTEM THROUGH THE LUMEN OF THE NON-ABBOTT GUIDING SHEATH AND THAT THE CATHETER TIP HAD BROKEN OFF. UNDER FLUOROSCOPY, IT WAS NOTED THAT THE SUPERA STENT WAS PARTLY PULLED INTO THE LUMEN OF THE NON-ABBOTT GUIDING SHEATH AND THE SEPARATED TIP WAS CAUGHT BETWEEN THE DISTAL END OF THE GUIDING SHEATH AND THE PROXIMAL END

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9541067 ↗
• MalfunctionNov 4, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. THE SUPERA STENT DELIVERY SYSTEM WAS LOADED ONTO THE GUIDE WIRE, WITHOUT RESISTANCE; HOWEVER, THE TIP OF THE STENT DELIVERY SYSTEM WAS MISSING. THE MISSING TIP WAS NOT FOUND. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9276171 ↗
• InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 75% STENOSED, NARROW, AND NON-CALCIFIED DE NOVO LESION IN THE COMMON FEMORAL ARTERY. ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT (EVT) WITH CONTRALATERAL ACCESS AND A POPLITEAL PUNCTURE. A 7X40 NON-ABBOTT STENT WAS DEPLOYED; HOWEVER, TWO DAYS LATER ACUTE ARTERIAL OCCLUSION OCCURRED. ANGIOGRAPHY WAS PERFORMED AND CONFIRMED STENOSIS IN THE PREVIOUSLY DEPLOYED STENT AND POPLITEAL PUNCTURE. A 6X50MM NON-ABBOTT STENT WAS PLACED AT THE SITE OF THE PREVIOUSLY DEPLOYED NON-ABBOTT STENT AND A 5.5X80MM SUPERA SELF-EXPANDING STENT WAS DEPLOYED IN BETWEEN THE P2 AND P1. FOLLOWING DEPLOYMENT OF THE SUPERA STENT A VASCULAR RUPTURE WAS OBSERVED AT THE SITE OF THE POPLITEAL PUNCTURE. A 4X30MM NON-ABBOTT STENT WAS DEPLOYED TO SUCCESSFULLY STOP THE BLEEDING. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 8675930 ↗
• InjuryFeb 20, 2019Material Separation; Improper or Incorrect Procedure or Method; Activation Failure; Material Separation; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT AN ENDARTERECTOMY WAS PERFORMED ON BOTH THE RIGHT AND LEFT ILIAC ARTERIES AND BOTH SIDES WERE PATCHED. A SHEATH WAS THEN INSERTED FROM THE RIGHT SIDE OVER THE COMMON ILIAC TO TREAT A MODERATELY CALCIFIED LESION IN THE PROXIMAL LEFT POPLITEAL ARTERY. AFTER PRE-DILATATION, THE 5.5 X 80 MM SUPERA SELF-EXPANDING DELIVERY SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE AND THE STENT WAS DEPLOYED UNDER FLUOROSCOPY. WHEN THE SUPERA SESS WAS WITHDRAWN FROM THE PATIENT ANATOMY, THE TIP WAS NOTED TO BE MISSING AND REMAINED INSIDE THE PATIENT ANATOMY. UNDER ANGIOGRAPHY, IT WAS NOTED THAT THE STENT HAD BEEN PULLED BACK INTO THE COMMON FEMORAL ARTERY AND THE SEPARATED TIP WAS INSIDE OF IT. IT WAS THEN REALIZED THAT DURING DEPLOYMENT, THE PHYSICIAN DID NOT UNLOCK THE SECOND LOCK; THEREFORE, THE STENT HAD NOT FULLY DEPLOYED AND WAS PULLED BACK DURING REMOVAL OF THE SESS. A CUT DOWN WAS PERFORMED AT A PREVIOUSLY CLOSED PATCH TO REMOVE THE STENT AND TIP FROM THE PATIENT ANATOMY. THE PATIENT REMAINED STABLE. THE PROCEDURE WAS ABORTED WITH BALLOON ANGIOPLASTY ONLY PERFORMED AT THE LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8354104 ↗