Supera™ S-70-060-120-P6Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648344268), received between Mar 9, 2023 and Dec 22, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Stretched; Activation Failure; Stretched; Activation Failure

  SUBSEQUENTLY, DEVICE ANALYSIS IDENTIFIED THAT THE TIP JACKET WAS SEPARATED FROM THE BASE OF THE TIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872832 ↗
• InjuryNov 5, 2024Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. THE 7.0X60 SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND THE STENT WAS DEPLOYED; HOWEVER, THE USER FAILED TO RETURN THE LEVER TO REAR POSITION TO LOCK THE HANDLE PRIOR TO REMOVING THE DELIVERY SYSTEM FROM THE PATIENT. THEREFORE, THE TIP OF THE DELIVERY SYSTEM BECAME DETACHED WHILE IN THE PATIENT AND HAD TO BE SNARED TO BE REMOVED. THERE WAS NOT ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20614343 ↗
• MalfunctionNov 5, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY THAT IS 90% STENOSED. USING A 6F GUIDING SHEATH FROM THE CONTRALATERAL SIDE ALONG WITH A 7.0X60MM SUPERA SELF-EXPANDING STENT THE STENT WAS DEPLOYED. POST DILATATION WAS ATTEMPTED; HOWEVER, IT WAS NOTED THAT THE STENT WAS NOT IN ITS DEPLOYED POSITION AND WAS NOTED TO BE IN GUIDING SHEATH. IT WAS NOTED WHEN REMOVING THE SUPERA DELIVERY SYSTEM THE STENT WAS PULLED BACK INADVERTENTLY INTO THE SHEATH. THE GUIDING SHEATH ALONG WITH THE STENT WERE REMOVED. A NEW SAME SIZE SUPERA STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612987 ↗
• MalfunctionFeb 29, 2024Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RESTENOSED, 7.0 MM RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 100% STENOSIS. THE VESSEL WAS PREPARED WITH A 4X20 MM NON-ABBOTT BALLOON AT 12 ATMOSPHERES FOR 60 SECONDS, TWICE, AND ATHERECTOMY WAS NOT USED. THERE WAS A VASCULAR OCCLUSION CAUSED BY THE FRACTURE OF A NON-ABBOTT STENT THAT HAD BEEN IMPLANTED IN THE ROOT OF THE RIGHT SFA. PRE-DILATATION WAS PERFORMED AND THE 7X60 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. THE STENT WAS IMPLANTED BUT THERE WAS RESISTANCE IN THE SHEATH DURING ADVANCEMENT OF A BALLOON FOR POST DILATATION. IT WAS NOTED THAT THE TIP OF THE SUPERA SESS HAD TORN AND THIS WAS CONFIRMED WHEN THE TIP CAME OUT OF THE SHEATH WHEN THE BALLOON WAS ADVANCED FURTHER. THE SHEATH WHICH WAS ALREADY INSIDE THE ANATOMY WAS THEN ADVANCED TO THE TORN TIP AND IT WAS RETRIEVED. REPORTEDLY, THE PHYSICIAN DID NOT PUT THE THUMBSLIDE BACK TO THE STARTING POSITION. THE TIP SEEMED TO TEAR WHEN THERE WAS RESISTANCE AT THE TIP OF THE SHEATH WHEN THE SESS WAS REMOVED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18810787 ↗
• InjuryMar 9, 2023Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT COMMON FEMORAL ARTERY. A 7.0X60MM SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND THE STENT IMPLANTED; HOWEVER, AFTER STENT DEPLOYMENT, IT WAS REALIZED THAT THE THUMB SLIDE WAS NOT LOCKED BEFORE STENT DEPLOYMENT, RESULTING IN THE TIP OF THE DEVICE SEPARATING FROM THE DEVICE.. THE TIP WAS SUCCESSFULLY SNARED IN THE SUPERFICIAL FEMORAL ARTERY, COMPLETING THE INTERVENTION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518894 ↗