Absolute Pro 1012537-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648176227), received between Mar 5, 2018 and Nov 25, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE LEFT EXTERNAL ILIAC ARTERY. THE 9.0X40MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION; HOWEVER HALFWAY THROUGH DEPLOYMENT, THE THUMBWHEEL BECAME STUCK AND WOULD NOT MOVE ANY FURTHER. WITHOUT BEING ABLE TO VISUALLY CONFIRM THE STENT WAS SECURE IN THE LESION, THE SES WAS PULLED BACK, WHICH RELEASED THE REMAINDER OF THE STENT WITHOUT ISSUE IN THE TARGET LESION. SUBSEQUENTLY, POST-DILATATION WAS PERFORMED TO ENSURE THE STENT WAS SECURE IN THE LESION. 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 23643689 ↗
• InjuryAug 6, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED LESION IN THE RIGHT COMMON ILIAC ARTERY. THE 9.0X40MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND THE STENT DEPLOYED WITHOUT ISSUE; HOWEVER, THE SESS COULD NOT BE REMOVED. THE SESS WAS PULLED BACK AND THE PROXIMAL SHAFT MARKER WAS OUT OF THE SHEATH BUT THE DISTAL SHAFT MARKER WOULD NOT EXIT THE DEPLOYED STENT. THE PROXIMAL END OF THE DEPLOYED STENT WAS BALLOONED AND THE SESS COULD BE REMOVED. THE STENT WAS FULLY DEPLOYED AT THE INTENDED SITE. 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 19918551 ↗
• MalfunctionJun 2, 2023Premature Activation; Difficult to Remove; Improper or Incorrect Procedure or Method; Premature Activation; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED DURING PREPARATION OF THE 9.0X40MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) RESISTANCE WAS FELT WHEN REMOVING THE STYLET. AS IT WAS CONTINUED TO BE PULLED THE STENT BEGAN DEPLOY. IT WAS NOTED THAT THE DEVICE WAS NOT FLUSHED PRIOR TO TAKING OUT THE MANDREL. THEREFORE, A NEW SAME SIZE ABSOLUTE PRO WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050917 ↗
• InjuryJul 26, 2022Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION. THE 9.0X40MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE AND THE STENT DEPLOYED WITHOUT RESISTANCE OR DIFFICULTIES, HOWEVER, IT WAS NOTED APPROXIMATELY 10-15MM OF THE DISTAL END OF THE STENT APPEARED TO BE UNRAVELED AND BROKEN. THE REST OF THE STENT DEPLOYED AS NORMAL. THE SESS WAS REMOVED AND POST DILATATION WAS PERFORMED WITH A 8.0X40MM BALLOON PER STANDARD PRACTICE AND TO MAKE SURE THE DISTAL END OF THE STENT WAS EXPANDED TO ALLOW PLACEMENT OF ANOTHER STENT INSIDE IT. THEN A 10X20MM ABSOLUTE PRO STENT WAS DEPLOYED INSIDE THE DISTAL END OF THE STENT AS TREATMENT AND WAS ALSO POST-DILATED PER STANDARD PRACTICE. THERE WAS NO NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15107996 ↗
• InjuryApr 26, 2022Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Mechanical Jam; Activation Failure; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT ON (B)(6) 2022, A PERCUTANEOUS PERIPHERAL INTERVENTION WAS PERFORMED ON THE RIGHT COMMON ILIAC ARTERY, MILDLY CALCIFIED LESION. AN ABSOLUTE PRO VASCULAR STENT DELIVERY SYSTEM (SDS) ADVANCED WITH DIFFICULTY DUE TO THE STEEP AORTIC BIFURCATION. ONCE AT THE RIGHT COMMON ILIAC, DEPLOYMENT WAS ATTEMPTED, HOWEVER, THE THUMBWHEEL WAS DIFFICULT TO TURN AND THEN STOPPED TURNING. THE STENT HAD ONLY PARTIALLY DEPLOYED. STANDARD TROUBLESHOOTING WAS PERFORMED, RETRACTING THE SHEATH, HOWEVER THE ISSUE REMAINED. DURING SDS REMOVAL, THE DEVICE WAS DIFFICULT TO REMOVE DUE TO THE STEEP BIFURCATION AND DIFFICULT TO RETRACT THE STENT INTO THE NON-ABBOTT SHEATH. DURING REMOVAL ATTEMPT, THE NON-ABBOTT OUTER SHEATH HAD SEPARATED, REQUIRING SNARE FOR REMOVAL, AND THE PARTIALLY DEPLOYED STENT HAD DISLODGED. THE PARTIALLY DEPLOYED STENT DEPLOYED FULLY AT AN UNINTENDED AREA, IN THE LEFT COMMON ILIAC ARTERY. IT WAS DECIDED TO LEAVE THE FULLY DEPLOYED STENT AT THIS LOCATION. A NON-ABBOTT STENT WAS SUCCESSFULLY IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY. THERE WAS NO ADVERSE PATIENT SEQUELA, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14213190 ↗
• MalfunctionMar 5, 2018Break

  IT WAS REPORTED THAT AN ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE RIGHT EXTERNAL ILIAC ARTERY WITHOUT RESISTANCE. DURING ADVANCEMENT, THE PROXIMAL CATHETER, ATTACHED TO THE DEVICE HANDLE, SEPARATED. THE SESS, CONTAINING THE UNDEPLOYED STENT WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. A NON-ABBOTT DEVICE WAS USED IN REPLACEMENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7313613 ↗