Absolute Pro 1012534-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648175992), received between May 4, 2018 and Dec 11, 2025 — classified as 4 injuries, 9 malfunctions.

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

• MalfunctionDec 11, 2025Break; Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure; Break; Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED, SUPERFICIAL FEMORAL ARTERY. THE 6.0X60MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT (SES) OVER A 0.018" GUIDEWIRE, COMPLETELY FAILED TO DEPLOY AS THE THUMBWHEEL COULD NOT TURN. THE ABSOLUTE PRO VASCULAR SES WAS WITHDRAWN AND THE STENT WAS NOTED TO HAVE BROKEN STENT STRUTS. AN UNSPECIFIED DEVICE 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 23783180 ↗
• InjuryJul 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE EXTERNAL ILIAC OF THE RIGHT LEG WITH MODERATE CALCIFICATION. THE 6.0X60MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) HAD NO ISSUES DURING DEPLOYMENT; HOWEVER, THE LAST PORTION OF THE STENT DID NOT FULLY EXPAND AFTER IT WAS RELEASED. ANOTHER BALLOON WAS USED TO COMPLETELY EXPAND THE STENT AND FULLY APPOSE TO THE VESSEL WALL. THERE WAS NO ADVERSE PATIENT SEQUELAE 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 22580932 ↗
• MalfunctionJul 23, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL SUPERIOR FEMORAL ARTERY. A 6.0X60MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS PREPPED PER THE INSTRUCTIONS FOR USE AND A 6F SHEATH WAS USED. THE SESS WAS BEING ADVANCED THROUGH THE PEDAL ACCESS; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT AND IT WAS NOTED ON ANGIO THAT THE STENT BEGAN TO PREMATURELY DEPLOY WITHIN THE ANTERIOR TIBIAL ARTERY. THE SESS WAS REMOVED FROM THE PATIENT WITHOUT ISSUES WHILE BEING MONITORED ON ANGIO TO MAKE SURE IT DID NOT FULLY DEPLOY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 6.0X60MM ABSOLUTE PRO STENT. 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 22579856 ↗
• MalfunctionMay 6, 2025Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY TORTUOSITY AND CALCIFICATION. ORBITAL ATHERECTOMY WAS PERFORMED. THE 7X60 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) FAILED TO DEPLOY AND THE THUMBWHEEL WOULD NOT TURN AT ALL. THE STENT WAS NOT EXPOSED. THE DEVICE WAS REMOVED FROM THE ANATOMY, AND WHEN REMOVED FROM THE SHEATH, THE STENT EXPANDED WITH NO MANIPULATION. THE 6X60 ABSOLUTE PRO SESS WAS ADVANCED. THE DEVICE PARTIALLY DEPLOYED INSIDE THE ANATOMY AND THEN ONCE OUTSIDE, IT FULLY DEPLOYED WITH NO MANIPULATION. A NON-ABBOTT BALLOON EXPANDABLE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 21971940 ↗
• InjuryNov 27, 2024Difficult or Delayed Activation; Difficult to Advance; Physical Resistance/Sticking; Difficult or Delayed Activation; 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 20799611 ↗
• MalfunctionAug 21, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 70% STENOSED LESION IN THE ILIAC ARTERY. A 6.0X60MMX135CM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION WITHOUT ISSUE, HOWEVER THE STENT WOULD NOT DEPLOY. THE DEVICE WAS REMOVED WITHOUT ISSUE AND ANOTHER ABSOLUTE PRO STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. THE RETURNED DEVICE ANALYSIS FOUND THE STENT WAS MISSING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17589217 ↗
• MalfunctionJun 29, 2023Malposition of Device; Physical Resistance/Sticking; Malposition of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE LEFT COMMON ILIAC ARTERY. THE 6.0X60MM ABS PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND RESISTANCE WAS NOTED WITH THE ADVANCING THE THUMBWHEEL DURING DEPLOYMENT WHILE RETRACTING THE SHEATH. THE STENT FLOWERED; HOWEVER, THE STENT JUMPED WHEN DEPLOYED. THE STENT DEPLOYED PARTIALLY IN THE TARGET LESION AND PARTIALLY IN HEALTHY TISSUE. ANOTHER ABSOLUTE PRO STENT WAS DEPLOYED TO COVER THE ADDITIONAL AREA OF THE LESION THAT WAS NOT COVERED BY THE INITIALLY DEPLOYED STENT. 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 17232006 ↗
• MalfunctionSep 8, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE 6.0X60MM ABSOLUTE PRO POUCH WAS REMOVED FROM THE CHIPBOARD BOX AND DEVICE FELL ON THE FLOOR, RENDERING IT UNSTERILE. IT WAS NOTED THAT THE BOTTOM EDGE OF THE STERILE POUCH WAS NOT SEALED WELL. ANOTHER SAME SIZE ABSOLUTE PRO WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380783 ↗
• InjuryApr 7, 2021Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY THAT WAS HEAVILY CALCIFIED. AN ABSOLUTE PRO VASCULAR WAS DEPLOYED BUT A STENT FRACTURE WAS OBSERVED. ANOTHER ABSOLUTE PRO VASCULAR STENT WAS DEPLOYED BUT ANOTHER STENT FRACTURE WAS OBSERVED. THERE WAS ADDITIONAL DISEASE TO TREAT SO A THIRD ABSOLUTE PRO WAS SUCCESSFULLY DEPLOYED. A NON-ABBOTT STENT WAS THEN DEPLOYED TO COVER THE FRACTURES OF THE FIRST TWO STENTS THAT WERE DEPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT IS FINE WITH NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 11627884 ↗
• MalfunctionJan 29, 2020Break; Break

  N/A.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9644136 ↗
• 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 9417383 ↗
• MalfunctionOct 22, 2018Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL OSTIUM OF THE SUPERFICIAL FEMORAL ARTERY. A 6.0X60MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION; HOWEVER, DURING DEPLOYMENT THE STENT JUMPED ABOUT 5 MILLIMETERS. THE STENT WAS POST-DILATED WITH A 5X40MM ARMADA 35 BALLOON CATHETER. ALTHOUGH THE STENT WAS IN THE TARGET LESION AN ADDITIONAL 6.0X20MM ABSOLUTE PRO VASCULAR SESS WAS ADVANCED AND DEPLOYED TO COVER THE REMAINDER OF THE TARGET LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH POST-DILATION WITH AN ARMADA 35 BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7992958 ↗
• MalfunctionMay 4, 2018Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 6X60MM ABSOLUTE PRO SELF-EXPANDING STENT WAS DEPLOYED; HOWEVER, THE STENT SYSTEM BECAME STUCK ON THE GUIDE WIRE DURING REMOVAL. BOTH THE STENT SYSTEM AND THE GUIDE WIRE WERE REMOVED AS A UNIT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7488646 ↗