Absolute Pro 1012534-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648176005), received between Dec 19, 2018 and Apr 9, 2026 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 95% STENOSIS. THE 6X80 MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION VIA A COMMAND 18 GUIDE WIRE. THE DEVICE WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE THUMBWHEEL WOULD NOT ROTATE AND THE DEVICE COMPLETELY FAILED TO DEPLOY THE STENT. A 6X80 MM ABSOLUTE PRO VASCULAR SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE STENT WAS PARTIALLY DEPLOYED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829968 ↗
• MalfunctionMar 31, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE 6X100 ABS PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITH RESISTANCE OVER A NON-ABBOTT 0.035 GUIDE WIRE (GW); HOWEVER, THE SESS WAS ABLE TO REACH THE TARGET LESION. THE STENT WAS ATTEMPTED TO BE DEPLOYED, BUT THE THUMBWHEEL WAS STUCK AND THE STENT COMPLETELY FAILED TO DEPLOY. THEREFORE, THE SESS WAS REMOVED FROM THE PATIENT AND ANOTHER 6X100MM ABS PRO WAS ABLE TO BE ADVANCED OVER THE SAME GW AND IMPLANTED WITHOUT ISSUE. THEN, A 6X80MM ABS PRO SESS WAS ADVANCE AND INTENDED TO BE IMPLANTED PROXIMAL TO THE PREVIOUSLY IMPLANTED STENT; HOWEVER, THE 6X80MM SESS FAILED TO CROSS THE TARGET LESION DUE TO THE ANATOMY AND THE SHEATH OF THE STENT WAS NOTED TO BE STRETCHED (BROKE). THE 6X80MM SESS WAS REMOVED FROM THE PATIENT WITHOUT ISSUE AND A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION. RETURN DEVICE ANALYSIS FOUND THE 6X100 ABS PRO STENT IMPLANT WAS EXPOSED 3 MM FROM THE DISTAL END OF THE SHEATH. THE STENT SHEATH WAS RETRACTED 6 MILLI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21735127 ↗
• MalfunctionMar 26, 2025Break; Improper or Incorrect Procedure or Method; Material Deformation; Activation Failure; Break; Improper or Incorrect Procedure or Method; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6X80MM ABSOLUTE PRO WAS ADVANCED OVER A .014" NON-ABBOTT GUIDEWIRE, AND ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT COULD ONLY BE PARTIALLY DEPLOYED AND WAS REMOVED AS A SINGLE UNIT STILL ON THE DELIVERY SHAFT. ANOTHER STENT WAS USED TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21697644 ↗
• InjuryNov 27, 2024Difficult or Delayed Activation; Malposition of Device; Difficult to Advance; Physical Resistance/Sticking; Difficult or Delayed Activation; Malposition of Device; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND 90% STENOSED, DE NOVO, LESION IN THE SUPERFICIAL FEMORAL ARTERY USING THREE ABSOLUTE PRO SELF-EXPANDING STENT SYSTEMS (SESS). AN UNSPECIFIED 0.035 GUIDE WIRE WAS ADVANCED, AND THE FIRST 6.0X80 ABSOLUTE PRO SESS WAS ADVANCED; HOWEVER, UNSPECIFIED RESISTANCE WAS NOTED, MAKING TRACKING DIFFICULT. DEPLOYMENT WAS INITIATED AND NOTED AS DIFFICULT DUE TO STIFFNESS IN TURNING THE THUMBWHEEL. AFTER STENT DEPLOYMENT, THE PHYSICIAN NOTED THE STENT WAS NOT FULLY EXPANDED, NECESSITATING THE USE OF A 6.0X200MM DILATATION CATHETER BALLOON TO FULLY EXPAND THE STENT. AFTER BALLOON EXPANSION, THE STENT JUMPED FORWARD BETWEEN 2MM AND 5MM, REMAINING PARTIALLY IN THE TARGET LESION AND ALSO IN HEALTH TISSUE. THE SECOND 6.0X80MM ABSOLUTE PRO WAS ADVANCED AND EXPERIENCED THE SAME OCCURRENCE. NEXT, THE THIRD 6.0X60MM ABSOLUTE PRO WAS DEPLOYED AND EXPERIENCED THE SAME OCCURRENCE; HOWEVER, THIS STENT REMAINED IN PLACE AFTER BALLOON EXPANSION. A FOURTH 6.0X100MM ABSOLUTE PRO WAS IMPLANTED TO TREAT THE TARGET AREAS LEFT UNCOVERED BY THE PREVIOUS STENTS MOVING FORWARD. THIS STENT ALSO ENCOUNTERED UNSPECIFIED RESISTANCE DURING ADVANCEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800017 ↗
• InjuryNov 27, 2024Difficult or Delayed Activation; Malposition of Device; Difficult to Advance; Physical Resistance/Sticking; Difficult or Delayed Activation; Malposition of Device; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND 90% STENOSED, DE NOVO, LESION IN THE SUPERFICIAL FEMORAL ARTERY USING THREE ABSOLUTE PRO SELF-EXPANDING STENT SYSTEMS (SESS). AN UNSPECIFIED 0.035 GUIDE WIRE WAS ADVANCED, AND THE FIRST 6.0X80 ABSOLUTE PRO SESS WAS ADVANCED; HOWEVER, UNSPECIFIED RESISTANCE WAS NOTED, MAKING TRACKING DIFFICULT. DEPLOYMENT WAS INITIATED AND NOTED AS DIFFICULT DUE TO STIFFNESS IN TURNING THE THUMBWHEEL. AFTER STENT DEPLOYMENT, THE PHYSICIAN NOTED THE STENT WAS NOT FULLY EXPANDED, NECESSITATING THE USE OF A 6.0X200MM DILATATION CATHETER BALLOON TO FULLY EXPAND THE STENT. AFTER BALLOON EXPANSION, THE STENT JUMPED FORWARD BETWEEN 2MM AND 5MM, REMAINING PARTIALLY IN THE TARGET LESION AND ALSO IN HEALTH TISSUE. THE SECOND 6.0X80MM ABSOLUTE PRO WAS ADVANCED AND EXPERIENCED THE SAME OCCURRENCE. NEXT, THE THIRD 6.0X60MM ABSOLUTE PRO WAS DEPLOYED AND EXPERIENCED THE SAME OCCURRENCE; HOWEVER, THIS STENT REMAINED IN PLACE AFTER BALLOON EXPANSION. A FOURTH 6.0X100MM ABSOLUTE PRO WAS IMPLANTED TO TREAT THE TARGET AREAS LEFT UNCOVERED BY THE PREVIOUS STENTS MOVING FORWARD. THIS STENT ALSO ENCOUNTERED UNSPECIFIED RESISTANCE DURING ADVANCEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799504 ↗
• InjuryOct 4, 2023Difficult to Remove; Mechanical Jam; Activation Failure; Difficult to Remove; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X80MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WOULD NOT DEPLOY COMPLETELY AND WAS STUCK WITHIN THE CATHETER. THUMBWHEEL BECAME STUCK AND WOULD NOT ADVANCE THUS MAKING IT IMPOSSIBLE TO COMPLETE DEPLOYMENT OF THE STENT. THE STENT SYSTEM WAS REMOVED THROUGH THE SHEATH DRAGGED TO THE COMMON FEMORAL ARTERY (CFA) ACCESS SITE. STENT WAS PULLED OUT AND STUCK IN THE SHEATH WHICH CAUSED DELAY IN PROCEDURE AND DAMAGE TO ACCESS SITE. SURGICAL CUTDOWN WAS PERFORMED TO TREAT THE DAMAGED ACCESS SITE AND PROLONGED HOSPITALIZATION FOR ACCESS SITE HEALING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17868577 ↗
• MalfunctionJan 5, 2023Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 6.0X80MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION WITH A .035 SUPRACORE GUIDEWIRE; HOWEVER DURING DEPLOYMENT THE THUMBWHEEL RATCHET WAS ADVANCED WITH RESISTANCE. ALTHOUGH DEPLOYMENT WAS DIFFICULT THE STENT WAS IMPLANTED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16103446 ↗
• MalfunctionJan 27, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.0X80MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED OVER THE NON-ABBOTT .035 GUIDE WIRE WHEN RESISTANCE WAS MET AND THE SESS COULD NOT ADVANCE ANY FURTHER. THE SESS WAS REMOVED WITH RESISTANCE NOTED. THE PROCEDURE WAS COMPLETED AT THIS TIME WITH NO FURTHER INTERVENTION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11239199 ↗
• MalfunctionOct 1, 2020Difficult to Remove; Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure; Difficult to Remove; Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THERE WAS RESISTANCE WITH THE THUMB WHEEL OF THE 6.0X80 MM ABSOLULTE PRO SELF EXPANDING STENT (SES) AND THE DEVICE FAILED TO DEPLOY AT THE THROMBOTIC, SLIGHTLY DISSECTED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS SOME RESISTANCE WITH THE .018" GUIDE WIRE DURING REMOVAL, WHICH CAUSED THE STENT TO PARTIALLY DEPLOY WHEN IT WAS OUTSIDE OF THE ANATOMY. A 7.0X60 MM ABSOLUTE PRO STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND 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 10614217 ↗
• InjuryNov 11, 2019Difficult or Delayed Positioning; Malposition of Device; Material Twisted/Bent; Difficult or Delayed Positioning; Malposition of Device; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. A 6X80MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) HAD VISIBILITY ISSUES, AND THE STENT WAS DEPLOYED PRIOR TO REACHING THE TARGET LESION DESPITE NOT KNOWING THE STENT'S LOCATION. THE STENT WAS NOWHERE TO BE FOUND AND COULD NOT BE CONFIRMED TO BE OUTSIDE THE PATIENT ANATOMY. AFTER REMOVAL, A BUNCHED TIP WAS NOTED ON THE DISTAL END OF THE DELIVERY CATHETER. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9304887 ↗
• InjuryDec 19, 2018Difficult or Delayed Activation; Mechanical Jam; Difficult or Delayed Activation; Mechanical Jam

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT ILIAC ARTERY. A 6.0X80MM X 135CM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND DEPLOYMENT WAS INITIATED. THE DIAL ON THE SESS HANDLE WOULD NOT CONTINUE TO MOVE AT THE POINT THE STENT WAS HALFWAY DEPLOYED. THE DELIVERY SYSTEM THEN LOCKED UP, AND THE PHYSICIAN THEN MANUALLY SPLIT OPEN THE SESS HANDLE TO PUSH THE ROD FORWARD TO DEPLOY THE REMAINING PORTION OF THE STENT IN THE TARGET LESION. THE PROCEDURE CONCLUDED AFTER THE STENT WAS DEPLOYED. IT WAS CONFIRMED THAT THE DELIVERY SYSTEM WAS NOT KINKED, AND THE THUMBWHEEL WAS NOT DIFFICULT TO TURN DURING THE STENT DEPLOYMENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8182733 ↗