SUPERA S-65-150-120-P6 (UDI 08717648226328)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08717648226328), received between Nov 14, 2018 and Sep 30, 2026 — classified as 7 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (7 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Stretched; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947469 ↗
• InjuryMay 6, 2026Material Separation; Stretched; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS POPLITEAL ARTERY LESION WITH 80% RESTENOSIS. A 6.5 X 150 MM SUPERA SELF-EXPANDING STENT WAS IMPLANTED. HOWEVER, THE THUMBSLIDE WAS NOT RETRACTED, AND LEVERS WERE NOT LOCKED. THEREFORE, THE STENT BECAME EXTREMELY ELONGATED, AND THE NOSE CONE WAS SEPARATED FROM THE DELIVERY SYSTEM AFTER REMOVING THE DEVICE FROM SHEATH. A SNARE WAS USED TO REMOVE THE SEPARATED TIP FROM THE DISTAL POPLITEAL ARTERY. AN ADDITIONAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096163 ↗
• InjurySep 17, 2025Material Separation; Stretched; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Material Separation; Stretched; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DISTAL POPLITEAL TO PROXIMAL SUPERFICIAL FEMORAL ARTERY(SFA). CONTRA-LATERAL ACCESS TO THE LESION WAS GAINED USING A 6FR SHEATH THAT WAS INTRODUCED IN THE RIGHT GROIN. FOLLOWING ACCESS TO THE LESION, THE VESSEL WAS PRE-TREATED WITH THROMBECTOMY AND ORBITAL ATHERECTOMY. THREE SUPERA PERPHERIAL SELF-EXPANDING STENTS WERE SUCCESSFULLY IMPLANTED WITH NO ISSUES. A 6MM NON-ABBOTT BALLOON WAS USED FOR PRE-DILATATION OF THE LAST TARGET VESSEL, AND THE 6.5X150MM SUPERA SELF EXPANDING STENT WAS ATTEMPTED TO BE DEPLOYED IN THE SFA WITH THE DISTAL PORTION OF THE 6FR SHEATH REMAINING IN THE COMMON FEMORAL ARTERY. HALFWAY THROUGH DEPLOYMENT, THE DELIVERY CATHETER CONE WAS NOTED TO BE CAUGHT ON THE DEPLOYED STENT, SUBSEQUENTLY CAUSING THE TIP OF DELIVERY CATHETER TO SEPARATE. THE REMAINING POTION DELIVERY CATHETER AND PARTIALLY DEPLOYED STENT WERE ATTEMPTED TO BE REMOVED CAUSING THE STENT TO BE INADVERTENTLY STRETCH. THE STENT WAS DEPLOYED IN THE EXTERNAL ILIAC WITH ONLY PART OF THE STENT REMAINING AT THE TARGET LESION. THE SEPARATED TIP WAS REMOVED VIA SNARE AND THE PROCEDURE WAS COMPLETED WITH A NON ABBOTT STENT. THERE WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23078386 ↗
• MalfunctionMay 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN REMOVING THE 6.50X150MM SUPERA SELF EXPANDING STENT SYSTEM WAS REMOVED FROM THE PACKAGING, IT WAS NOTED THE NOSE CONE WAS SEPARATED. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. 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 22034825 ↗
• MalfunctionNov 27, 2024Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY THAT IS 90% STENOSED. THE 6.5X150MM SUPERA PERIPHERAL STENT SYSTEM WAS PARTIALLY DEPLOYED TO ABOUT 10CM AS IT WAS NOTED THAT THE THUMBSLIDE BECAME DIFFICULT TO USE AND COULD NO LONGER MOVE. THE SUPERA WAS REMOVED UNDER FLUOROSCOPY AND A NEW 6.5X150MM SUPERA WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799827 ↗
• InjuryNov 11, 2022Difficult to Remove; Stretched; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT DISTAL SUPERIOR FEMORAL ARTERY (SFA). THE 6.5X150MM SUPERA SELF-EXPANDING STENT WAS DEPLOYED; HOWEVER, DURING REMOVAL UNDER FLUOROSCOPY THE TIP OF SUPERA DELIVERY SYSTEM BECAME CAUGHT ON THE DEPLOYED STENT. THIS CAUSED STENT ELONGATION TO 200 LENGTH INSTEAD OF THE ORIGINAL 150 LENGTH. THE PHYSICIAN UNLOCKED SYSTEM AND TRIED TO SLIDE THE THUMBSLIDE TO SEE IF NOSECONE WOULD MOVE FORWARD TO DISENGAGE THE STENT. HE ADVANCED THE ENTIRE DELIVERY SYSTEM FORWARD AND WAS ABLE TO GET IT TO DISENGAGE. ADDITIONAL BALLOON DILATATION WAS PERFORMED WITH AN 6.0MM ARMADA 35 BALLOON DILATATION CATHETER TO IMPROVE THE STENT LUMEN. SOME OF THE STENT IS IN HEALTHY TISSUE. THE PROFUNDA WAS ALMOST COVERED BY THE STENT THAT WAS MEANT TO TREAT THE DISTAL SFA IN THE RIGHT LEG. THERE WERE NO ADVERSE PATIENT SEQUELA REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15780600 ↗
• MalfunctionOct 28, 2022Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT TO A HEAVILY CALCIFIED, MILDLY TORTUOUS DE NOVO SUPERFICIAL FEMORAL ARTERY THAT IS 100% STENOSED. USING A CROSSOVER FEMORAL ARTERY ACCESS, PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON. THE 6.5X150MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) THUMBSLIDE BECAME JAMMED DURING DEPLOYMENT OF THE STENT AND THE SESS PARTIALLY DEPLOYED. THE SESS WAS REMOVED FROM THE ANATOMY UNDER FLUOROSCOPY. IT WAS NOTED THAT ISSUE WITH THUMBSILDE COULD'VE BEEN DUE TO THE STEEP ANGLE OF TERMINAL AORTA AS AFTER THE DEVICE WAS REMOVED THE THUMBSLIDE WAS ABLE TO BE MANIPULATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 7.0X150MM NON-ABBOTT STENT AND ANOTHER IMPLANTED IN THE DISTAL AREA. 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 15692831 ↗
• MalfunctionApr 26, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. A 6 FR SHEATH WAS USED, THE VESSEL 6.5MM IN DIAMETER AND THE LESION LENGTH WAS 130MM. A NON-ABBOTT 300CM GUIDEWIRE WAS USED AND PRE-DILATATION WAS PERFORMED WITH A 7.0X100MM NON-ABBOTT BALLOON AT 18 ATMOSPHERES (ATMS) FOR 30 SECONDS. ATHERECTOMY WAS NOT USED. USING A CROSS OVER APPROACH, A 6.5X150MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND DURING DEPLOYMENT THE STENT PARTIALLY DEPLOYED. THE INTRODUCER SHEATH WAS CLOSE TO THE PROXIMAL END OF THE STENT DURING DEPLOYMENT. THE THUMBSLIDE WAS MOVED SEVERAL TIMES FOR TROUBLESHOOTING, BUT IT DIDN'T DEPLOY. THE SESS WAS REMOVED UNDER FLUOROSCOPY. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SUPERA STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14215141 ↗
• InjuryMar 29, 2022Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100% STENOSED LESION IN THE RIGHT FEMORAL ARTERY. PRE-DILATATION WAS PERFORMED. THE 6.5X150MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED, HOWEVER, THE DEPLOYMENT LOCK DID NOT WORK AND FAILED TO DEPLOY THE STENT. THE PATIENT HAD RENAL FAILURE DUE TO AMOUNT OF CONTRAST MEDIUM USED AND THERE WAS UNPLANNED MEDICATION AND PROLONGED HOSPITALIZATION. THE PATIENT IS CONTROLLED AND CONTINUES WITH MEDICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Renal Failure

  MAUDE report 13938737 ↗
• InjuryFeb 8, 2022Product Quality Problem; Material Separation; Product Quality Problem; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100% STENOSED, DE NOVO LESION WITH CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. PRE-DILATATION WAS PERFORMED WITH A 5.0 X 240MM NON-ABBOTT BALLOON CATHETER AND A 6.0 X 60MM NON-ABBOTT STENT WAS IMPLANTED DISTAL TO THE TARGET LESION. SUBSEQUENTLY, A 6.50 X 120MM SUPERA STENT WAS IMPLANTED PROXIMAL TO THE NON-ABBOTT STENT. THEN A 6.5 X 150 SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS DEPLOYED AT THE PROXIMAL END OF THE TARGET LESION; HOWEVER THE TIP OF THE SESS SEPARATED DURING DEPLOYMENT. ALTHOUGH THE SEPARATED TIP REMAINED ON THE GUIDEWIRE, A SNARE DEVICE WAS USED TO REMOVE THE SEPARATED TIP. POST-DILATATION WAS COMPLETED WITH A NON-ABBOTT BALLOON, ENDING THE PROCEDURE. THE PHYSICIAN STATED THE STRUCTURE OF TIP WAS TOO WEAK. THERE WAS NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13482049 ↗
• MalfunctionNov 10, 2021Device Dislodged or Dislocated; Activation Failure; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED. DURING THE INTERVENTION, A SUPERA STENT HAD DISLODGED FROM THE DELIVERY CATHETER AND WAS REMOVED FROM THE PATIENT. IT IS UNKNOWN AT WHAT POINT THIS ISSUE OCCURRED. THERE WAS NO ADVERSE PATIENT SEQUELA NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787420 ↗
• MalfunctionAug 18, 2021Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT DURING A SUPERFICIAL TO COMMON FEMORAL ARTERY INTERVENTION, AFTER LESION PREPARATION, THE SUPERA 6.5X150 MM STENT SYSTEM WAS ADVANCED TO THE LESION AND DEPLOYMENT INITIATED. AFTER PARTIAL DEPLOYMENT, STRONG RESISTANCE ADVANCING THE THUMBSLIDE WAS NOTED. FORCE WAS APPLIED, BUT THE THUMBSLIDE FAILED TO MOVE. DURING DEVICE REMOVAL, A PORTION OF THE STENT DEPLOYED INSIDE THE INTRODUCER SHEATH; THEREFORE, THE STENT AND DELIVERY SYSTEM WERE REMOVED BY USING THE SHEATH. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. A SUPERA 6.5X80 MM WAS IMPLANTED AT THE LESION WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339868 ↗
• MalfunctionOct 23, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING INSPECTION AT CENTURY MEDICAL INC. IT WAS NOTED THAT THREE SUPERA DEVICES (6.5X150MM) WERE NOTED TO HAVE A CRACK ON THE PRODUCT. THE DEVICES WERE NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURN DEVICE ANALYSIS FOR ALL THREE 6.5X150MM SUPERAS IDENTIFIED THAT A PIECE OF THE STRAIN RELIEF MATERIAL WAS SEPARATED AT THE DISTAL END OF THE OF THE STRAIN RELIEF.

  Patient problems: No Patient Involvement

  MAUDE report 9225298 ↗
• MalfunctionOct 23, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING INSPECTION AT CENTURY MEDICAL INC. IT WAS NOTED THAT THREE SUPERA DEVICES (6.5X150MM) WERE NOTED TO HAVE A CRACK ON THE PRODUCT. THE DEVICES WERE NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURN DEVICE ANALYSIS FOR ALL THREE 6.5X150MM SUPERAS IDENTIFIED THAT A PIECE OF THE STRAIN RELIEF MATERIAL WAS SEPARATED AT THE DISTAL END OF THE OF THE STRAIN RELIEF.

  Patient problems: No Patient Involvement

  MAUDE report 9225216 ↗
• MalfunctionOct 23, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING INSPECTION AT CENTURY MEDICAL INC. IT WAS NOTED THAT THREE SUPERA DEVICES (6.5X150MM) WERE NOTED TO HAVE A CRACK ON THE PRODUCT. THE DEVICES WERE NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURN DEVICE ANALYSIS FOR ALL THREE 6.5X150MM SUPERAS IDENTIFIED THAT A PIECE OF THE STRAIN RELIEF MATERIAL WAS SEPARATED AT THE DISTAL END OF THE OF THE STRAIN RELIEF.

  Patient problems: No Patient Involvement

  MAUDE report 9225169 ↗
• MalfunctionSep 23, 2019Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT RESTENOSIS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) THAT WAS 20% STENOSED. THE DISTAL SIDE OF THE SFA WAS PRE-DILATED WITH A 6X130MM NON-ABBOTT BALLOON DILATATION CATHETER. A 6.5X150MM SUPERA STENT WAS DEPLOYED FROM THE MIDDLE TO THE DISTAL SIDE OF THE SFA. PER THE PHYSICIAN, THE DEPLOYMENT WAS COMPLETED SMOOTHLY. DURING REMOVAL OF THE DELIVERY SYSTEM, IT WAS NOTED THAT THE STENT HAD BEEN PARTIALLY DEPLOYED IN THE GUIDING CATHETER. IT WAS CONFIRMED VIA CINEANGIOGRAPHY THAT WHILE MOVING THE GUIDING CATHETER, THE STENT MOVED PROXIMAL FROM THE TARGET AREA. THE STENT AND DELIVERY SYSTEM WERE RETRIEVE WITH THE GUIDING CATHETER AS A SINGLE UNIT. A 7X120MM AND A 7X80MM NON-ABBOTT STENTS WERE SUCCESSFULLY DEPLOYED 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 Consequences Or Impact To Patient

  MAUDE report 9105602 ↗
• InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 6.0X150 MM SUPERA SELF EXPANDING STENT (SES) WAS IMPLANTED AND ONE DAY LATER THE PATIENT EXPERIENCED THROMBOSIS. THE PATIENT WAS ASYMPTOMATIC; HOWEVER THE PHYSICIAN SUSPECTED THROMBOSIS AS THE AREA WAS THE SAME COLOR AS BEFORE THE PROCEDURE. ANGIOGRAPHY WAS PERFORMED TO CONFIRM THE THROMBOSIS. THE THROMBOSIS WAS TREATED WITH ASPIRATION AND THROMBECTOMY AND UROKINASE WAS ADMINISTERED. THE PATIENT HAS IMPROVED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 8413928 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2018 TO TREAT A SEVERELY CALCIFIED RIGHT POPLITEAL AND SUPERFICIAL FEMORAL ARTERY. A 6.0X100MM SUPERA STENT WAS IMPLANTED IN THE RIGHT PROXIMAL POPLITEAL, AND A 6.5X150MM SUPERA STENT WAS IMPLANTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), OVERLAPPING THE 6.0X100MM SUPERA STENT. THERE WERE NO REPORTED ISSUES DURING THE PROCEDURE. THE PATIENT WAS COMPLIANT WITH PLAVIX AND ASPIRIN MEDICATIONS FOLLOWING THE PROCEDURE; HOWEVER, THE DOSAGE IS UNKNOWN. ON (B)(6) 2019, THE PATIENT PRESENTED WITH LEG CLAUDICATION AND A SEVERELY CALCIFIED RIGHT POPLITEAL AND SFA. ANGIOGRAPHY DISCOVERED RESTENOSIS IN THE PREVIOUSLY IMPLANTED SUPERA STENTS AND THROMBUS DISTAL TO THE STENTS THAT SHUT DOWN BOTH STENT SEGMENTS AND RESULTED IN NO FLOW. A NON-ABBOTT STENT WAS DEPLOYED AND SUFFICIENTLY RESTORED THE BLOOD FLOW. THERE WAS NO ADVERSE PATIENT SEQUELA, AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Claudication; Stenosis; Thrombosis

  MAUDE report 8376029 ↗
• MalfunctionNov 14, 2018Stretched; Difficult or Delayed Activation; Noise, Audible; Physical Resistance/Sticking; Stretched; Difficult or Delayed Activation; Noise, Audible; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED, SUPERFICIAL FEMORAL ARTERY (SFA), THE RACHET WAS NOISY AND STICKING, MAKING IT DIFFICULT TO DEPLOY THE STENT. AN UNSUCCESSFUL ATTEMPT WAS MADE TO RETRACT AND REMOVE THE PARTIALLY DEPLOYED STENT AND DURING MANIPULATION OF THE DELIVERY SYSTEM, THE STENT FULLY DEPLOYED; HOWEVER, THE STENT ELONGATED AND ABOUT 3 CM WAS OUTSIDE THE TARGET LESION AREA. NO ADDITIONAL TREATMENT/INTERVENTION WAS PERFORMED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8071213 ↗