Absolute Pro 1012538-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648176319), received between Sep 12, 2019 and Apr 16, 2026 — classified as 4 injuries, 5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED EXTERNAL ILIAC ARTERY LESION. A 10X100 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER THE SHEATH WAS UNABLE TO BE RETRACTED AND THE STENT COULD NOT BE DEPLOYED. THE SES WAS REMOVED AND ANOTHER SAME SIZE ABSOLUTE PRO SES WAS ADVANCED TO THE TARGET LESION HOWEVER THE STENT WAS ONLY ABLE TO DEPLOY A THIRD OF THE WAY. THE SES WITH THE STENT WAS REMOVED AND THE PROCEDURE COMPLETED USING A NON-ABBOTT STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANALYSIS OF THE FIRST RETURNED DEVICE INDICATED THAT THE STENT IMPLANT WAS EXPOSED 2MM FROM THE DISTAL END OF THE SHEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899812 ↗
• MalfunctionApr 16, 2026Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED EXTERNAL ILIAC ARTERY LESION. A 10X100 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER THE SHEATH WAS UNABLE TO BE RETRACTED AND THE STENT COULD NOT BE DEPLOYED. THE SES WAS REMOVED AND ANOTHER SAME SIZE ABSOLUTE PRO SES WAS ADVANCED TO THE TARGET LESION HOWEVER THE STENT WAS ONLY ABLE TO DEPLOY A THIRD OF THE WAY. THE SES WITH THE STENT WAS REMOVED AND THE PROCEDURE COMPLETED USING A NON-ABBOTT STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANALYSIS OF THE FIRST RETURNED DEVICE INDICATED THAT THE STENT IMPLANT WAS EXPOSED 2MM FROM THE DISTAL END OF THE SHEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899769 ↗
• InjuryJun 15, 2022Improper or Incorrect Procedure or Method; Malposition of Device; Mechanical Jam; Activation Failure; Improper or Incorrect Procedure or Method; Malposition of Device; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION AND HIGH AT TARGET LESION AND MODERATE TORTUOSITY. THE 10.0X100MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE THUMBWHEEL OF THE SESS WAS STUCK. WHILE ATTEMPTING TO REMOVE THE SESS, THE STENT FLOWERED APPROXIMATELY 2CM INTO THE SHEATH. THE SHEATH WAS PULLED BACK; HOWEVER THE STENT REMAINED IN THE PATIENT IN THE ILIAC BIFURCATION AND PARTIALLY IN THE TARGET LESION. THEN A SECOND 10.0 X 40MM ABSOLUTE PRO SESS WAS ATTEMPTED TO BE ADVANCED TO TREAT THE TARGET LESION; HOWEVER, IT WAS NOTED THAT THE FIRST STENT WAS DEPLOYED, PARTIALLY IN THE INTRODUCER SHEATH. THEREFORE, THE 10.0X40MM ABSOLUTE PRO FAILED TO BE INSERTED INTO THE VESSEL, SO THE DEVICE WAS REMOVED FROM THE PATIENT AND THE STENT DEPLOYED OUTSIDE THE PATIENT. THE PROCEDURE WAS ABORTED SINCE THE LESION HAD BEEN PREVIOUSLY DILATED. THERE WAS A DELAY IN PROCEDURE RESULTING IN INCREASED ANTICOAGULATION TIME AS WELL AS THE INABILITY TO TREAT THE LESION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14700942 ↗
• MalfunctionSep 20, 2021Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT EXTERNAL ILIAC ARTERY. THE VESSEL WAS PREPARED WITH A 8.0X40MM NON-ABBOTT BALLOON AT NOMINAL PRESSURE. THE 10X100MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, RESISTANCE WAS FELT WITH THE THUMBWHEEL AND THE STENT WAS PARTIALLY DEPLOYED. THE SESS WAS REMOVED UNDER FLUOROSCOPY AND ONCE OUTSIDE THE ANATOMY IT WAS ATTEMPTED TO FULLY DEPLOY THE STENT, BUT FAILED. A NEW ABSOLUTE PRO WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12502296 ↗
• InjuryMay 20, 2021Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY WITH TIBIAL ACCESS ON THE RIGHT LEG. THERE WAS MODERATE CALCIFICATION AND NO TORTUOSITY NOTED. LASER ATHERECTOMY WAS PERFORMED AND A NON-ABBOTT STENT WAS DEPLOYED PROXIMALLY WITH NO ISSUES NOTED. THE 10X100 MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT (SES) WAS THEN DEPLOYED DISTALLY WITH NO ISSUES NOTED. POST-DILATATION WAS PERFORMED WITH A 6.0X40 MM UNSPECIFIED BALLOON. DURING POST-DILATATION, A PERFORATION IN THE MID PORTION OF THE ABSOLUTE PRO VASCULAR SES WAS DISCOVERED AND INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED A STENT FRACTURE IN THE SAME LOCATION AS THE PERFORATION. ACCESS WAS GAINED VIA RIGHT COMMON ANTEGRADE FASHION WITH AN 8FR SHEATH PLACED AND A NON-ABBOTT COVERED STENT WAS USED TO TREAT THE PERFORATION AND STENT FRACTURE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 11856681 ↗
• InjuryJul 28, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT COMMON ILIAC ARTERY. A 10X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS BEING ADVANCED WHEN THE STENT DEPLOYED PREMATURELY IN AN UNINTENDED SITE WITHOUT INITIATING DEPLOYMENT. A CUT DOWN WAS PERFORMED TO REMOVE THE STENT, AND THE PROCEDURE WAS ABORTED. THERE WERE NO ADVERSE PATIENT SEQUELAE, BUT THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10332273 ↗
• InjuryNov 25, 2019Difficult or Delayed Activation; Patient-Device Incompatibility; Physical Resistance/Sticking; Difficult or Delayed Activation; Patient-Device Incompatibility; Physical Resistance/Sticking

  ADDITIONAL INFORMATION: AFTER THE THUMB WHEEL COULD NO LONGER MOVE, FORCE WAS APPLIED AND THE 10X100MM ABSOLUTE PRO STENT RELEASED. THE DEPLOYED STENT WAS NOT FULLY APPOSED; THEREFORE, A SECOND STENT WAS USED TO FULLY DEPLOY THE STENT AND TRAP IT IN ITS LOCATION AND FULLY DEPLOY IT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9369385 ↗
• MalfunctionNov 25, 2019Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED ILIAC ARTERY. A 10X100MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) FELT RESISTANCE FROM THE ANATOMY BUT WAS ADVANCED TO THE TARGET LESION SUCCESSFULLY, AND THE STENT WAS IMPLANTED. THE DELIVERY SYSTEM FACED RESISTANCE WITH THE ANATOMY DURING REMOVAL, AND THE PROXIMAL SHAFT SEPARATED. THE DEVICE WAS SIMPLY WITHDRAWN, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE PROXIMAL SHAFT OF THE 10X100MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) DID NOT SEPARATE, BUT THE SHAFT JACKET WAS THE PORTION THAT SEPARATED. NO PORTION OF THE DEVICE REMAINS IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9369220 ↗
• MalfunctionSep 12, 2019Difficult or Delayed Activation; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Difficult or Delayed Activation; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND HEAVILY TORTUOUS DE NOVO LESION IN THE RIGHT COMMON ILIAC ARTERY. FOLLOWING PRE-DILATATION, A 10X100 ABSOLUTE PRO SELF EXPANDING STENT (SES) WAS ADVANCED VIA LEFT FEMORAL APPROACH. STENT DEPLOYMENT WAS STARTED; HOWEVER, THE THUMBWHEEL COULD NOT BE ROTATED. THE DISTAL END OF THE STENT WAS ALREADY APPOSED TO THE VESSEL; THEREFORE, WHEN THE DELIVERY SYSTEM WAS RELUCTANTLY PULLED BACK, THE STENT WAS DEPLOYED PRECISELY. THE PROCEDURE WAS COMPLETED. THE PHYSICIAN SUSPECTED THAT THE SHAFT HAD KINKED DUE TO TOUGH TORTUOSITY OF ILIAC ARTERY. THEREFORE, THE DEPLOYMENT ISSUE OCCURRED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9001015 ↗