Absolute Pro 1012537-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648176241), received between Sep 11, 2024 and Aug 14, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (2 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 16, 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.

• MalfunctionAug 14, 2025Off-Label Use; Difficult to Remove; Material Separation; Stretched; Difficult to Advance; Mechanical Jam; Activation Failure; Off-Label Use; Difficult to Remove; Material Separation; Stretched; Difficult to Advance; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT CHRONIC PATIENT EAR RINGING WITH STENT PLACEMENT IN THE SIGMOID SINUS VEIN WITH HEAVY TORTUOSITY. THE 9X80MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE THE INTENDED LOCATION WITH RESISTANCE DUE TO THE SIGNIFICANT TORTUOSITY. THE STENT WAS ATTEMPTED TO BE RELEASED; HOWEVER, THE STENT WAS ONLY PARTIALLY DEPLOYED WHEN THE THE THUMBWHEEL BECAME STUCK. THEREFORE, THE SESS WAS REMOVED AND DURING REMOVAL RESISTANCE WAS ALSO NOTED AND THE PARTIALLY DEPLOYED STENT BECAME INTERTWINED WITH THE GUIDE WIRE (GW) AND INTRODUCER SHEATH. THE SESS WAS ABLE TO BE REMOVED TOGETHER WITH THE GW AND INTRODUCER SHEATH. AFTER REMOVAL, THE STENT WAS NOTED TO HAVE BECAME STRETCHED AND THE DELIVERY SHEATH HAD A SEPARATION. TO CONTINUE THE PROCEDURE, A 8X80MM ABSOLUTE PRO SESS WAS ADVANCED TO THE INTENDED LOCATION WITHOUT ISSUE; HOWEVER, WHEN THE HANDLE OF THE SESS WAS UNLOCKED THE THUMBWHEEL BECAME STUCK AFTER ON 3MM OF THE SENT BECAME EXPOSED. THE SECOND SESS WAS REMOVED FROM THE PATIENT AND THE STENT SHEATH WAS NOTED TO BE SEPARATED. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22807869 ↗
• InjurySep 11, 2024Stretched; Activation Failure; Stretched; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT EXTERNAL ILIAC ARTERY WITH 80% STENOSIS. A 7X60 MM ARMADA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER WAS USED FOR ANGIOPLASTY AND THEN THE 9X80 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND DEPLOYED. DURING DEPLOYMENT, THE STENT PARTIALLY DEPLOYED AND WAS ABOVE THE LESION, SO THE STENT WAS PULLED. THIS STRETCHED THE STENT INTO THE COMMON FEMORAL ARTERY (CFA) AND PART REMAINED IN THE TARGET LESION. RIGHT COMMON FEMORAL ACCESS WAS OBTAINED AND THE STENT WAS BALLOONED WITH A 6X40 MM ARMADA PTA CATHETER. THEN A LASER WAS USED IN THE PROXIMAL AND MID SUPERFICIAL FEMORAL ARTERY (SFA). THE 6X40 MM ARMADA WAS USED TO ACHIEVE HEMOSTASIS ON THE LEFT CFA IN ORDER TO TREAT THE SFA AS THE LONG SHEATH NEEDED TO BE REMOVED FROM THE LEFT CFA TO BE PLACED IN THE RIGHT CFA. THERE WAS NO HEMORRHAGE. THE ARMADA BALLOONS FUNCTIONED AS INTENDED WITHOUT ISSUE. A NON-ABBOTT 7X150 MM STENT WAS DEPLOYED IN THE EXTERNAL ILIAC ARTERY. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192473 ↗