SUPERA S-50-060-120-P6Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08717648211744), received between Nov 14, 2016 and Jun 22, 2026 — classified as 6 injuries, 11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND 90% STENOSIS. THE LESION WAS PRE-DILATED WITH A 5X100 MM ARMADA BALLOON. THE 5X60 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND THE STENT WAS DEPLOYED. WHEN THE DELIVERY SYSTEM WAS REMOVED OVER THE WIRE, THE STENT WAS ATTACHED TO THE NOSE CONE AND CAME OUT WITH THE DELIVERY SYSTEM. ANOTHER SUPERA SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25586555 ↗
• InjuryJun 19, 2024Migration; Migration

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE RIGHT POPLITEAL ARTERY. THE 5.0X60MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION AND DEPLOYMENT STARTED HOWEVER THE GUIDE WIRE MOVED PROXIMAL. THE SES WAS RETRACTED AFTER IT WAS THOUGHT THE STENT HAD FULLY DEPLOYED HOWEVER THE STENT RETRACTED TOO AND ENDED UP IN THE SUPERFICIAL FEMORAL ARTERY (SFA). ALTHOUGH NOT INTENDED, THE PHYSICIAN WAS HAPPY WITH THE PLACEMENT OF THE STENT IN THE SFA. ANOTHER SUPERA STENT WAS PLACED IN THE TARGET LESION TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19567017 ↗
• InjuryApr 26, 2024Difficult to Remove; Material Separation; Device Dislodged or Dislocated; Activation Failure; Difficult to Remove; Material Separation; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT POPLITEAL ARTERY WITH A VESSEL DIAMETER OF 5MM. PRE-DILATION WAS PERFORMED WITH AN UNSPECIFIED 5MM BALLOON. THROUGH A 6FR 45CM SHEATH, THE 5.0X60 SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED OVER A 0.018 GUIDE WIRE TO THE TARGET SITE AND THE THUMBWHEEL WAS ENGAGED WITH NO ISSUES. NOTHING WAS SEEN ON FLUOROSCOPY SO THE PHYSICIAN ATTEMPTED TO RETRACT THE STENT BACK INTO THE SHEATH; HOWEVER IT WAS FOUND THAT THE STENT HAD PARTIALLY DEPLOYED AND COULD NOT BE REMOVED. UNDER FLUOROSCOPY, WITHDRAWAL WAS STILL ATTEMPTED AND THE STENT COMPLETELY DEPLOYED IN AN UNINTENDED LOCATION, THE AORTIC BIFURCATION AND THE NOSE CONE OF THE SUPERA DETACHED FROM THE CATHETER. THE STENT WAS REMOVED DURING A CUT DOWN SURGICAL PROCEDURE IN THE OPERATING ROOM WHERE A BALLOON WAS INFLATED IN THE STENT AND REMOVED FROM THE ANATOMY. THE NOSE CONE WAS RETRIEVED WITH A SNARE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192786 ↗
• MalfunctionJan 19, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS PRE-DILATED WITH AN UNSPECIFIED DEVICE AND A 5.0X60 6F SUPERA SELF-EXPANDING STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, ONLY PARTIALLY DEPLOYED. THE DELIVERY SYSTEM AND STENT WERE REMOVED UNDER FLUOROSCOPY WITHOUT COMPLICATIONS. THE STENT IMPLANTATION WAS ABORTED. 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 13293708 ↗
• InjuryDec 3, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY/ PROXIMAL POPLITEAL ARTERY THAT WAS 75% RESTENOSED. PRE-DILATATION WAS PERFORMED WITH A BALLOON. A 5X60MM SUPERA STENT WAS DEPLOYED AS NORMAL. HOWEVER, UNDER FLUOROSCOPY IT WAS NOTED THAT THERE WAS NO STENT IMPLANT IN THE LOCATION. WHEN THE DELIVERY SYSTEM WAS BEING WITHDRAWN, THERE WAS SOME RESISTANCE MET WITH THE SHEATH. VIA FLUOROSCOPY IT WAS CONFIRMED THAT THE STENT WAS CAUGHT IN THE SHEATH. THE GUIDE WIRE WAS MANEUVERED THROUGH THE UNDEPLOYED STENT THAT WAS IN THE SHEATH, AND THE SHEATH WAS EXCHANGED IN ORDER TO REMOVE THE STENT FROM THE PATIENT. ANOTHER SUPERA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925752 ↗
• MalfunctionAug 31, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING SUPERA PREPARATION, THE NOSE CONE (TIP) APPEARED LOOSE. THE DEVICE WAS BEING PREPPED PER INSTRUCTIONS FOR USE WITHOUT ANY OTHER ISSUE NOTED. IT COULD NOT BE CONFIRMED IF THE TIP WAS ACCIDENTLY PULLED DURING PREPARATION. THE DEVICE WAS DISCARDED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS DEVICE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12395197 ↗
• InjuryAug 26, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. A RETROGRADE APPROACH WAS MADE AND ANGIOPLASTY WAS PERFORMED. THE SUPERA STENT DELIVERY SYSTEM WAS ADVANCED AND DEPLOYMENT WAS INITIATED. HOWEVER, THE STENT PREMATURELY RELEASED ITSELF FROM THE DELIVERY SYSTEM. THE STENT FULLY COVERED THE TARGET LESION AND WAS FULLY IN THE TARGET LESION, BUT THE PROXIMAL END OF THE STENT WAS NOT FULLY EXPANDED. ADDITIONAL DILATATION WAS PERFORMED AT THE PROXIMAL STENT, FULLY EXPANDING THE STENT TO THE VESSEL WALL. POST PROCEDURE, THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10457867 ↗
• MalfunctionJun 3, 2020Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE POPLITEAL ARTERY. A 5.0X60MM SUPERA STENT WAS DEPLOYED. AN ATTEMPT TO REMOVE THE SELF-EXPANDING STENT SYSTEM (SESS) WAS MADE; HOWEVER, THE DETACHMENT LOCK TAB COULD NOT BE UNLOCKED. SEVERAL ATTEMPTS WERE MADE BUT THE TAB WOULD NOT MOVE. THE SESS WAS REMOVED UNDER FLUOROSCOPY IN THE DEPLOYED POSITION AND THE STENT WAS REMOVED WITH THE SESS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 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 10114670 ↗
• InjurySep 4, 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 NON-TORTUOUS, NON-CALCIFIED SUPERFICIAL FEMORAL ARTERY. THREE SUPERA STENTS (5.0X80MM, 5.0X60MM, AND 5.5X120MM) AND A NON-ABBOTT STENT WERE SUCCESSFULLY PLACED IN THE LESION. BLOOD FLOW WAS LIMITED AS ONLY A TRICKLE WAS NOTED THROUGH THE STENTS. A BLOCKAGE WAS SUSPECTED BUT UNABLE TO IDENTIFY OR CONFIRM AS THROMBUS. BYPASS SURGERY WAS DONE AS TREATMENT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion

  MAUDE report 8962190 ↗
• InjuryJun 24, 2019Break; Break

  IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT APPROXIMATELY 8 MONTHS POST IMPLANT OF A 5 X 60 MM SUPERA TREATING A SUBTOTAL OCCLUSION OF THE POPLITEAL ARTERY, THE PATIENT PRESENTED WITH RIGHT LIMB CLAUDICATION, AND ABSENT PULSES OF THE RIGHT FOOT. RADIOGRAPHY WAS PERFORMED, NOTING THE STENT WAS FRACTURED AND RE-STENOSED/OCCLUDED. SURROUNDING VESSELS WERE PATENT. CONSIDERING THAT RECANALIZATION OF THE VESSEL WAS NOT POSSIBLE, A POPLITEAL TO POPLITEAL BYPASS WAS PERFORMED. THE PROCEDURE WAS SUCCESSFUL AND POST-OPERATIVE COURSE UNEVENTFUL. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED FRACTURE OF A SUPERA INTERWOVEN NITINOL STENT AFTER TREATMENT OF POPLITEAL ARTERY STENOSIS. PLEASE SEE ARTICLE FOR ADDITIONAL INFORMATION.

  Patient problems: Stenosis

  MAUDE report 8728469 ↗
• MalfunctionMay 7, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN INCOMING INSPECTION AT THE DISTRIBUTION CENTER, A 5.0 X 60 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS REJECTED FOR FOREIGN MATERIAL IN THE PACKAGING. THERE WERE NO REPORTED PROBLEMS WITH THE STERILITY OF THE DEVICE. AS THE COSMETIC NON-CONFORMITY WAS NOTED AT THE DISTRIBUTION CENTER THERE WAS NO PATIENT INVOLVEMENT. THE SESS UNIT WERE NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED GOODS ANALYSIS IDENTIFIED THAT THE FOREIGN MATERIAL IN THE PACKAGING WAS A MANUFACTURING COMPONENT.

  Patient problems: No Patient Involvement

  MAUDE report 8587737 ↗
• MalfunctionJan 21, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING UNPACKING OF THE 5.0X60MM SUPERA SELF EXPANDING STENT SYSTEM, THE NOSE CONE WAS NOTED TO BE BROKEN OFF. THE DEVICE WAS NOT USED AND REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8264192 ↗
• MalfunctionAug 20, 2018Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7798773 ↗
• MalfunctionAug 13, 2018Premature Activation; Product Quality Problem; Improper or Incorrect Procedure or Method; Failure to Advance; Premature Activation; Product Quality Problem; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE ANTERIOR TIBIAL ARTERY WITH A VESSEL DIAMETER OF 3.0MM. A 6F NON-ABBOTT INTRODUCER SHEATH WAS PLACED AT THE PEDAL ACCESS POINT AND AN UNSPECIFIED .018 GUIDE WIRE WAS ADVANCED TO THE LESION. PRE-DILATATION WAS PERFORMED WITH A 5.0MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER. A 5.0X60MMX120CM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND WOULD NOT CROSS THE LESION DUE TO THE MILD CALCIFICATION. FORCE WAS APPLIED AND THE SESS STILL WOULD NOT CROSS THE LESION AND WAS INDIVIDUALLY REMOVED FROM THE PATIENT ANATOMY WITHOUT RESISTANCE. UPON SESS REMOVAL, THE TIP WAS OBSERVED TO HAVE MOVED AND THE DISTAL PORTION OF THE STENT HAD FLOWERED. THE SESS TIP WAS NOT SEPARATED AND THE DEPLOYMENT AND SYSTEM LOCKS WERE LOCKED IN PLACE. A NON-ABBOTT SHEATH GAINED ACCESS THROUGH THE RIGHT FEMORAL ARTERY. ANOTHER SAME SIZED SUPERA SESS WAS ADVANCED AND THE STENT WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7779256 ↗
• MalfunctionSep 26, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE NOSECONE SEPARATED [PULLED OFF] FROM THE SUPERA DEVICE DURING PREPARATION OF THE DEVICE. THE CATH LAB TECHNICIAN THOUGHT THE NOSECONE TO BE THE STYLET AND PULLED IT OFF. THE DEVICE WAS NOT USED. ANOTHER SUPERA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION AS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6894567 ↗
• MalfunctionSep 25, 2017Inaccurate Delivery

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT DISTAL SFA AND PROXIMAL POPLITEAL ARTERY. WHEN THE 5.0 X 60 MM SUPERA PERIPHERAL STENT WAS DEPLOYED, THE STENT JUMPED AND WAS APPOSED TO THE WALL DISTAL TO THE INTENDED LOCATION. A 5 X 8 MM SUPERA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE WITH NO ISSUES NOTED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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 6892433 ↗
• MalfunctionNov 14, 2016Difficult or Delayed Positioning

  IT WAS REPORTED THAT THUMB SLIDE WORKED FINE, BUT THE 5.0 X 60 SUPERA STENT WAS DIFFICULT TO DEPLOY IN THE PREDILATED, 5 MM DIAMETER, SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN MOVED THE THUMB SLIDE BACK AND FORTH UNTIL THE STENT WAS EVENTUALLY COMPLETELY RELEASED. IT WAS RELEASED COMPLETELY WITHIN ITS TARGET AREA. 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 6099840 ↗