SUPERA S-50-020-120-P6Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648211720), received between Mar 11, 2020 and May 29, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A RESTENOSIS LESION AT SEVERAL DIFFERENT PREVIOUSLY IMPLANTED STENTS WITHIN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND MID POPLITEAL WITH A 5MM VESSEL DIAMETER. THE VESSEL WAS PREPARED USING A NON-ABBOTT ATHERECTOMY DEVICE AS WELL AS PRE-DILATATION WITH A 5MM JADE BALLOON DILATATION CATHETER (BDC) TO 12ATMS FOR 30SECS. A 5X20MM SUPERA PERIPHERAL SELF-EXPANDING STENT (SES) WAS ADVANCED THROUGH A 6FR SHEATH TO A LESION IN THE MID POPLITEAL, AND THE DEPLOYMENT LOCK WAS UNLOCKED AND THE THUMB SLIDE WAS ADVANCED TO THE MOST DISTAL POSITION ON THE HANDLE. HOWEVER, DURING WITHDRAWAL, UNDER FLUOROSCOPY, IT WAS NOTED THAT THE STENT WAS NOT FULLY DEPLOYED FROM THE DELIVERY CATHETER AND INSTEAD WAS INADVERTENTLY PULLED AND DEPLOYED IN THE PROXIMAL SFA WITH NO PART OF THE STENT IN THE TARGET LESION. THEREFORE, A 5MM ARMADA 18 BDC WAS USED TO POST-DILATE AND FULLY APPOSE THE SUPERA STENT TO THE VESSEL WALL, AND THE PROCEDURE WAS COMPLETED WITH SIMPLE BALLOON ANGIOPLASTY. THERE WAS NO ADVERSE PATIENT SEQUELA NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22105748 ↗
• MalfunctionMar 11, 2020Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-TORTUOUS, HEAVILY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. THE 5.0X20MM SUPERA STENT WAS DEPLOYED USING A 6-FRENCH (70CM) SHEATH. DURING RETRIEVAL OF THE DELIVERY CATHETER, THE STENT CAME OUT WITH IT. OUTSIDE OF THE ANATOMY, THE TIP SEPARATED FROM THE CATHETER. A NEW SUPERA STENT WAS IMPLANTED 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 Consequences Or Impact To Patient

  MAUDE report 9818230 ↗