SUPERARecalls & reported problems across all models

We found 55 models of SUPERA by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 752 adverse event reports in the FDA's MAUDE database, received between Aug 2, 2016 and Sep 30, 2026 — classified as 342 injuries, 410 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (246 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SUPERA problems

SUPERA models

55 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SUPERA S-60-150-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  108 reports
• SUPERA S-55-150-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  88 reports
• SUPERA S-50-120-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  55 reports
• SUPERA S-60-120-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  40 reports
• SUPERA S-50-080-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  23 reports
• SUPERA S-50-100-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  22 reports
• SUPERA S-60-080-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  22 reports
• SUPERA S-60-100-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  22 reports
• SUPERA S-55-120-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  22 reports
• SUPERA S-60-060-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  21 reports
• SUPERA S-55-150-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  21 reports
• SUPERA S-55-040-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  20 reports
• SUPERA S-65-150-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  19 reports
• SUPERA S-60-040-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  18 reports
• SUPERA S-65-040-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  18 reports
• SUPERA S-50-060-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  17 reports
• SUPERA S-55-060-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  17 reports
• SUPERA S-55-100-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  17 reports
• SUPERA S-65-080-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  15 reports
• SUPERA S-45-120-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  14 reports
• SUPERA S-55-080-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  14 reports
• SUPERA S-65-150-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  12 reports
• SUPERA S-50-040-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  11 reports
• SUPERA S-65-120-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  9 reports
• SUPERA S-55-040-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  9 reports
• SUPERA S-45-080-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  7 reports
• SUPERA S-45-100-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  7 reports
• SUPERA S-55-120-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  7 reports
• SUPERA S-45-060-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  6 reports
• SUPERA S-55-100-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  6 reports
• SUPERA S-45-040-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  5 reports
• Supera™ S-70-060-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  5 reports
• SUPERA S-55-060-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  5 reports
• SUPERA S-65-060-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  4 reports
• SUPERA S-65-100-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  4 reports
• SUPERA S-45-060-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  4 reports
• SUPERA S-45-080-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  4 reports
• SUPERA S-45-100-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  4 reports
• SUPERA S-45-120-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  4 reports
• SUPERA S-60-030-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  3 reports
• SUPERA S-55-080-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  3 reports
• SUPERA S-50-020-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• Supera™ S-75-060-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• Supera™ S-70-100-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• SUPERA S-65-060-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• SUPERA S-65-080-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• SUPERA S-65-120-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• SUPERA S-50-030-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• SUPERA S-65-030-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• Supera™ S-75-100-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• Supera™ S-70-030-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• SUPERA S-45-040-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• SUPERA S-65-100-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• SUPERA S-45-030-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• SUPERA S-65-020-120-P6

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report

Recent SUPERA adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 29, 2026Activation Failure

  It was reported that the procedure was to treat a de novo lesion in the lower limb with 70% stenosis, mild calcification and mild tortuosity. The 6.0x150mm Supera self-expanding stent system (SESS) was advanced, but then during stent deployment, the stent was only able to be partially deployed. The stent could not be fully released. Therefore, the delivery system and stent were removed under fluoroscopy without issues. Another same size Supera was used to complete the procedure. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927395 ↗
• 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 ↗
• MalfunctionAug 18, 2026Stretched; Difficult to Advance; Activation Failure; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50307531 ↗
• InjuryAug 11, 2026Material Separation; Improper or Incorrect Procedure or Method

  It was reported this was a procedure to treat a heavily calcified, heavily tortuous, and 98% stenosed superficial femoral artery. A Supera 5.0x120 was inserted and placed at the target lesion. However, after the stent was released and the delivery system was withdrawn from the body, the distal tip was found detached and trapped on the guide wire. It was noted the thumb slide was not fully retracted, and the system lock and deployment lock were not rotated into the locked position. A snare was inserted to retrieve the detached fragment. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50214011 ↗
• 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 ↗
• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6) IT WAS REPORTED THAT ON (B)(6) 2025 TWO ABSOLUTE PRO STENTS (6.0X100 AND 6.0X80 MM) AND ONE 5.0X12 MM SUPERA STENT WERE IMPLANTED IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (LSFA). ONE 6.0X100 MM, NON-ABBOTT STENT WAS ALSO IMPLANTED IN THE LSFA. IN (B)(6) 2025 THE PATIENT WAS FOUND TO HAVE THROMBUS (STENOSIS) WITHIN THE LSFA. BALLOON ANGIOPLASTY AND THROMBOLYSIS WERE PERFORMED. THE PHYSICIAN ASSESSED THAT THERE WAS LIKELY STENOSIS IN ALL FOUR IMPLANTED STENTS. THE PATIENT'S CONDITION HAS IMPROVED AND THE PATIENT WAS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25881993 ↗
• MalfunctionJul 17, 2026Stretched

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25857099 ↗
• MalfunctionJul 15, 2026Stretched; Difficult or Delayed Activation; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25822270 ↗
• InjuryJun 26, 2026Migration

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE POPLITEAL ARTERY. THE 5.50X150MM SUPERA SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING DEPLOYMENT, THE STENT SLIDE BACK TO THE COMMON FEMORAL ARTERY AND DID NOT MAINTAIN ITS STARTING POSITION IN THE PROXIMAL POPLITEAL ARTERY. A SECOND SUPERA STENT WAS IMPLANTED TO COVER THE TARGET LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25635075 ↗
• 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 ↗
• MalfunctionJun 16, 2026Stretched; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY LESION. THE 5.5X150 MM SUPERA SELF-EXPANDING STENT (SES) WAS ADVANCED TO THE TARGET LESION AND FULLY DEPLOYED. HOWEVER, DURING REMOVAL OF THE SES, ELONGATION OCCURRED AND THE STENT WAS REMOVED. THIS ALSO OCCURRED WITH THE SECOND 5.5X150 MM SUPERA SES AND THE THIRD 5.5X120 MM SUPERA SES. A FOURTH 5.5X150 MM SUPERA SES AND A NON-ABBOTT STENT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524240 ↗
• MalfunctionJun 16, 2026Stretched; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY LESION. THE 5.5X150 MM SUPERA SELF-EXPANDING STENT (SES) WAS ADVANCED TO THE TARGET LESION AND FULLY DEPLOYED. HOWEVER, DURING REMOVAL OF THE SES, ELONGATION OCCURRED AND THE STENT WAS REMOVED. THIS ALSO OCCURRED WITH THE SECOND 5.5X150 MM SUPERA SES AND THE THIRD 5.5X120 MM SUPERA SES. A FOURTH 5.5X150 MM SUPERA SES AND A NON-ABBOTT STENT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524239 ↗
• MalfunctionJun 16, 2026Stretched; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY LESION. THE 5.5X150 MM SUPERA SELF-EXPANDING STENT (SES) WAS ADVANCED TO THE TARGET LESION AND FULLY DEPLOYED. HOWEVER, DURING REMOVAL OF THE SES, ELONGATION OCCURRED AND THE STENT WAS REMOVED. THIS ALSO OCCURRED WITH THE SECOND 5.5X150 MM SUPERA SES AND THE THIRD 5.5X120 MM SUPERA SES. A FOURTH 5.5X150 MM SUPERA SES AND A NON-ABBOTT STENT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524237 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, ONE 6.0X100 MM ABSOLUTE PRO STENT AND ONE 5.5X150 MM SUPERA STENT WERE IMPLANTED IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). ON (B)(6) 2025, COMPUTED TOMOGRAPHY ANGIOGRAPHY SUGGESTED MULTI VESSEL STENOSIS AND OCCLUSION IN THE LOWER LIMB ARTERY. THE DEGREE OF IN-STENT RESTENOSIS WAS 60% IN BOTH THE SUPERA AND ABSOLUTE PRO STENTS. ON (B)(6) 2025, BALLOON ANGIOPLASTY OF THE RIGHT POSTERIOR TIBIAL ARTERY AND POPLITEAL ARTERY WAS PERFORMED. AFTERWARDS, THE PATIENT UNDERWENT HEMODIALYSIS. ON (B)(6) 2025, THE PATIENT UNDERWENT A RIGHT SECOND TOE AMPUTATION SECONDARY TO DIABETIC FOOT GANGRENE. AFTER THE INTERVENTION, SYMPTOMATIC TREATMENT SUCH AS ANTI-INFECTION, PAIN RELIEF AND REHYDRATION WAS GIVEN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Impaired Healing; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 25364486 ↗

Other Abbott Vascular Inc. products

• MITRACLIP8 models · 5,973 reports · 2 recalls
• NC TREK56 models · 1,842 reports · 12 recalls
• Armada213 models · 1,904 reports
• Indeflator7 models · 1,196 reports · 9 recalls
• XIENCE Sierra56 models · 1,161 reports · 1 recall
• XIENCE Skypoint69 models · 1,142 reports
• Graftmaster15 models · 1,071 reports
• TREK50 models · 909 reports