Absolute Pro 1012534-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648175985), received between Mar 28, 2018 and Jun 2, 2026 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Premature Activation

  IT WAS REPORTED THAT WHEN THE ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS OPENED, THE STENT WAS NOTED TO BE PARTIALLY DEPLOYED AND FLOWERED. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER ABSOLUTE PRO SESS WAS USED TO COMPLETE THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE STENT WAS NOT FLOWERED AND WAS ONLY EXPOSED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363471 ↗
• MalfunctionApr 21, 2026Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE 6.0X40 MM ABSOLUTE STENT WAS VERY HARD TO DEPLOY IN THE 100% STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS FLUSHED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. IT WAS ADVANCED OVER AN .035 GUIDEWIRE AND WAS VERY DIFFICULT TO MOVE THE THUMB WHEEL TO DEPLOY. THE STENT WAS SUCCESSFULLY DEPLOYED IN POSITION BUT WITH DIFFICULTY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24943056 ↗
• MalfunctionMar 5, 2026Premature Activation; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE 6X40MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS PREPPED SUCCESSFULLY AND LOADED ONTO THE GUIDE WIRE, PRIOR TO ENTERING THE SHEATH, THE DISTAL END OF THE STENT WAS OBSERVED TO BE PROTRUDING. ALTHOUGH THE LOCKING MECHANISM REMAINED ENGAGED, THE STENT BECAME LODGED IN THE SHEATH VALVE, RESULTING IN THE STENT TO BECOME ELONGATED AND DETACHED FROM THE DELIVERY SYSTEM. THE DEVICE WAS NOT IMPLANTED AND WAS REPLACED WITH A NEW SESS, ALLOWING THE PROCEDURE TO BE COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524302 ↗
• MalfunctionJul 28, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING THE PROCEDURAL PREPARATION, THE 6X40MM ABSOLUTE PRO SELF-EXPANDING STENT (SES) WAS PARTIALLY DEPLOYED WHEN PULLED OUT OF PACKAGING; HOWEVER, THE STENT STRUTS WERE NOT FLOWERED. THEREFORE ANOTHER SAME SIZED ABSOLUTE PRO SES WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639579 ↗
• InjuryMay 20, 2025Premature Activation; Improper or Incorrect Procedure or Method; Mechanical Jam; Premature Activation; Improper or Incorrect Procedure or Method; Mechanical Jam

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE 70% STENOSED, MILDLY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AN UNSPECIFIED SUPERA STENT WAS DEPLOYED IN THE POPLITEAL ARTERY WITHOUT ISSUES. AN INTRAVASCULAR ULTRASOUND WAS PERFORMED AND DISEASE WAS NOTED PROXIMAL TO THE DEPLOYED SUPERA STENT. A 6X40MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS POSITIONED IN THE DISEASED SECTION AND READY TO DEPLOY; HOWEVER, AFTER UNLOCKING THE HANDLE THE THUMBWHEEL WAS REALLY HARD TO ROTATE. THE STENT FLOWERED AND ABOUT 15% WAS OUT. AN ATTEMPT TO PULL OUT THE WHOLE SESS WAS MADE BECAUSE THE THUMBWHEEL WOULD NOT MOVE, BUT AS THE SESS GOT CLOSER TO THE SHEATH THE STENT UNRAVELED ON IT'S OWN (DEPLOYED) AND IT WAS DEPLOYED IN UNINTENDED HEALTHY TISSUE IN THE PROXIMAL SFA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 6X60MM ABSOLUTE PRO STENT. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22055372 ↗
• InjuryFeb 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE COMMON FEMORAL ARTERY. A 6X40MM ABSOLUTE PRO SELF-EXPANDING STENT (SES) WAS DEPLOYED AT THE TARGET LESION; HOWEVER, A FRACTURE [SEPARATION] IN THE STENT WAS NOTED. A NON-ABBOTT STENT WAS DEPLOYED TO SECURE THE FRACTURED STENT AGAINST THE ARTERIAL WELL, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326870 ↗
• MalfunctionDec 30, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT UPON REMOVAL OF THE 6.0X40MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) FROM THE DISPENSER HOOP WITHOUT ISSUES, IT WAS NOTED THAT THE STRUTS WERE SLIGHTLY EXPOSED BUT NOT FLOWERED. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER ABSOLUTE PRO SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16077931 ↗
• MalfunctionJun 25, 2021Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE ABSOLUTE PRO SELF EXPAND STENT (SES) WAS USED TO TREAT A NON-ABBOTT VASCULAR CLOSURE DEVICE THAT HAD EMBOLIZED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE ABSOLUTE PRO WAS ADVANCED AND DURING DEPLOYMENT, THE THUMBWHEEL STOPPED TURNING WHEN THE STENT WAS ALMOST COMPLETELY DEPLOYED. THE PHYSICIAN WAS ABLE TO TUG ON THE DEVICE TO RELEASE THE STENT COMPLETELY. THE STENT WAS ABLE TO JAIL AND SECURE THE CLOSURE CLIP AGAINST THE VESSEL WALL IN THE SFA. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12066829 ↗
• MalfunctionMar 3, 2021Premature Activation; Material Deformation; Premature Activation; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY THAT WAS HEAVILY TORTUOUS. WHEN THE ABSOLUTE PRO STENT DELIVERY SYSTEM (SDS) REACHED THE TARGET LESION, IT WAS OBSERVED THAT 10MM OF THE STENT WAS STICKING OUT OF THE SHEATH. THE PHYSICIAN DECIDED TO PULL THE SDS BACK INTO THE SHEATH AND REMOVE FROM THE PATIENT. AT THAT POINT, IT WAS NOTED THAT THE STENT WAS DAMAGED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER ABSOLUTE PRO WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11405564 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA)/PROXIMAL POPLITEAL OCCLUSION. A 6.0X40MM ABSOLUTE PRO SELF-EXPANDING STENT WAS ADVANCED AND DEPLOYED; HOWEVER, DUE TO THE SUPPORT WIRE BEING INSERTED INTO THE WRONG VESSEL 1MM OF THE DISTAL END OF THE STENT WAS PLACED IN THE COLLATERAL VESSEL. IT WAS ATTEMPTED TO RETRIEVE/REPOSITION THE STENT THROUGH BALLOON MANIPULATION BUT WAS NOT POSSIBLE. THE STENT WALL WAS BLOCKING THE DESIRED GUIDE WIRE PATH. DUE TO THIS, THE PHYSICIAN WAS UNABLE TO PASS A WIRE THROUGH THE STENT STRUTS AS THE FEMORAL ARTERY/POPLITEAL WAS OCCLUDED (TARGET LESION) AT THIS SECTION AS WELL, MAKING CROSSING THE LESION MORE CHALLENGING. THE COLLATERAL VESSEL REMAINED PATENT AND IT WAS DECIDED TO TREAT THE PATIENT WITH MEDICAL MANAGEMENT WITH THE OPTION TO BYPASS AT A LATER TIME. NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10959295 ↗
• InjuryDec 5, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE POPLITEAL ARTERY AND BOTH STENTS PREMATURELY DEPLOYED. THE ABSOLUTE PRO VASCULAR 6.0X40 MM DEPLOYED IN THE SUPERFICIAL FEMORAL ARTERY AND THE ABSOLUTE PRO VASCULAR 6.0X60 MM DEPLOYED IN THE ILIAC ARTERY. THE STENTS WERE LEFT WHERE THEY WERE DEPLOYED, WHICH WAS ALSO DISEASED TISSUE. A NEW STENT WAS USED TO TREAT THE TARGET LESION. THERE WAS NO REPORTED RESISTANCE DURING ADVANCEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9417357 ↗
• MalfunctionDec 21, 2018Premature Activation; Difficult to Remove; Difficult to Advance; Premature Activation; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. AS THE ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS BEING ADVANCED ONTO AN UNSPECIFIED GUIDE WIRE THAT WAS AT THE TARGET LESION, RESISTANCE WAS NOTED AND IT FELT LIKE THE SESS WAS STICKING TO THE GUIDE WIRE. THE PHYSICIAN COULD NOT REMEMBER IF GUIDE WIRE HAD BEEN WIPED DOWN SO THE SESS WAS ATTEMPTED TO BE REMOVED. THERE WAS RESISTANCE WITH THE GUIDE WIRE DURING REMOVAL OF THE SESS. AS THE SESS WAS BEING BACKED OFF OF THE GUIDE WIRE, THE SHEATH PULLED BACK AND THE DISTAL PART OF THE STENT DEPLOYED AND BECAME FLOWERED. REPORTEDLY, THE STENT WAS CONFIRMED TO NOT BE EXPOSED PRIOR TO LOADING THE SESS ONTO THE GUIDE WIRE. ANOTHER ABSOLUTE PRO SESS AND GUIDE WIRE WERE USED TO SUCCESSFULLY 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 8191390 ↗
• InjuryMar 28, 2018Premature Activation; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PERIPHERAL PROCEDURE TO TREAT A TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE ABSOLUTE PRO VASCULAR STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY, BUT WAS UNABLE TO ADVANCE OVER THE STEEP BIFURCATION AT THE COMMON ILIAC ARTERY. AN ATTEMPT WAS MADE TO REMOVE THE STENT DELIVERY SYSTEM; HOWEVER, RESISTANCE WAS NOTED AND THE STENT DEPLOYED IN THE COMMON ILIAC ARTERY, WHILE STILL IN THE LOCK POSITION AND WITHOUT INITIATION OF THE THUMBWHEEL TO DEPLOY. THE STENT WAS NOTED TO BE WELL APPOSED TO THE VESSEL WALL AT SEVERAL POINTS AND NO ADDITIONAL INTERVENTION WAS PERFORMED. THE TARGET LESION WAS TREATED WITH A NON-ABBOTT STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7380006 ↗