Absolute Pro 1012535-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648176081), received between Dec 30, 2016 and Dec 23, 2025 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT ILIAC ARTERY. THE 7.0X80MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION OVER A SPARTACORE GUIDE WIRE HOWEVER DURING ATTEMPTED DEPLOYMENT, THE THUMBWHEEL KEPT SPINNING AND THE STENT WAS NOT ABLE TO BE DEPLOYED. THE SES WAS REMOVED FROM THE PATIENT AND A NON-ABBOTT 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. RETURN DEVICE ANALYSIS NOTED THE STENT WAS EXPOSED 5MM FROM THE DISTAL END OF THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878682 ↗
• InjurySep 30, 2024Difficult to Remove; Material Separation; Stretched; Mechanical Jam; Activation Failure; Difficult to Remove; Material Separation; Stretched; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT EXTERNAL ILIAC. A 7.0X80MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE LESION THROUGH THE COMMON FEMORAL ARTERY AND DEPLOYED AT THE TARGET LESION; HOWEVER DURING DEPLOYMENT THE THUMBWHEEL WAS NOTED TO STOP WITH PART OF THE STENT STILL INSIDE THE DELIVERY CATHETER. THE DEVICE WAS ATTEMPTED TO BE REMOVED HOWEVER RESISTANCE WAS FELT AND THE STENT WAS NOTED TO BE STRETCHED, WITH 50% IN THE TARGET LESION AND 50% STRETCHED AND LODGED IN THE RIGHT COMMON FEMORAL ARTERY. THE STENT SEPARATED AT THE STRETCHED PORTION IN THE TISSUE TRACK. A SURGICAL CUT DOWN WAS PERFORMED AT THE RIGHT COMMON FEMORAL ARTERY AND THE SEPARATED STENT WAS REMOVED. THE PART OF THE STENT THAT WAS SUCCESSFULLY DEPLOYED IN THE TARGET LESION WAS POST DILATED AND ANOTHER STENT WAS DEPLOYED TO COVER THE REMAINING PART OF THE LESION TO COMPLETE THE PROCEDURE. THERE WAS A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334104 ↗
• MalfunctionJul 8, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE LEFT EXTERNAL ILLIAC ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 7X80MM ABSOLUTE PRO SELF EXPANDING STENT WAS ADVANCED OVER A 0.035 HI-TORQUE VERSACORE FLOPPY GUIDE WIRE WITHOUT RESISTANCE. THE THUMBWHEEL WAS ENGAGED AND THE STENT DEPLOYED WITHOUT ISSUES. UPON WITHDRAWAL, RESISTANCE WAS FELT WITH THE GUIDE WIRE. SALINE WAS FLUSHED THROUGH THE ABSOLUTE PRO DELIVERY SYSTEM USING THE HYDROPLANE TECHNIQUE, IN ORDER TO SLIDE THE ABSOLUTE PRO DELIVERY SYSTEM OFF THE GUIDE WIRE. THE GUIDE WIRE WAS REMOVED AND PROXIMAL PORTION OF THE WIRE WAS NOTED TO BE BENT YET REMAINED INTACT. 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 19690911 ↗
• InjuryJun 11, 2024Difficult or Delayed Activation; Difficult to Advance; Mechanical Jam; Difficult or Delayed Activation; Difficult to Advance; Mechanical Jam

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DIMINISHED BLOOD FLOW AND THE PROCEDURE WAS TO TREAT A 70% STENOSED LESION IN THE LET EXTERNAL ILIAC ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. USING THE CROSSOVER APPROACH, THE 7X80MM ABS PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. DURING DEPLOYMENT OF THE STENT THE THUMBWHEEL WAS DIFFICULT TO TURN AND WHEN THE STENT HAD BEEN HALFWAY RELEASED THE THUMBWHEEL STOPPED TURNING. THEREFORE, THE PHYSICIAN OPENED THE HANDLE TO REMOVED THE WHEEL IN THE HANDLE AND MANUALLY COMPLETELY RELEASE THE STENT. BLOOD FLOW IMPROVED; HOWEVER, WAS REMAINED DIMINISHED DUE TO POOR ARTERY WALL STENT APPOSITION. THEREFOR, AN ABSOLUTE PRO STENT WAS DEPLOYED FOR BETTER WALL APPOSITION OF THE STENT. FLOW WAS RESTORED TO THE LEFT EXTERNAL ILIAC ARTERY. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PROCEDURE WAS COMPLETED WITH A PERCLOSE PROSTYLE CLIP TO CLOSE THE ACCESS SITE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512255 ↗
• InjuryNov 9, 2023Improper or Incorrect Procedure or Method; Defective Device; Device Damaged by Another Device; Difficult to Advance; Improper or Incorrect Procedure or Method; Defective Device; Device Damaged by Another Device; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUPERFICIAL FEMORAL ARTERY THAT IS 100% STENOSED. THE VESSEL WAS PRE-DILATED WITH A 6.0X200MM ARMADA 18 BALLOON AT NOMINAL PRESSURE. THE 7.0X80MM ABSOLUTE PRO SELF-EXPANDING STENT (SES) WAS IMPLANTED; HOWEVER, WHEN ATTEMPTING TO POST DILATE THE STENT, THE UNSPECIFIED BALLOON WAS ADVANCED INTO THE STENT; HOWEVER, THE STENT FOLDED IN ON ITSELF (ACCORDION) AND HAD TO PLACE A NON ABBOTT STENT AT THE DISTAL EDGE OF THE ABSOLUTE PRO TO COVER IT. THE DELIVERY SYSTEM WAS REMOVED UNDER FLUOROSCOPY. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103342 ↗
• MalfunctionNov 1, 2021Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT THE 7X8MM ABSOLUTE PRO SELF-EXPANDING STENT (SES) WAS BEING ADVANCED TO THE TARGET LESION WHEN THE STENT DEPLOYED IN THE INTRODUCER SHEATH. THE ISSUE WAS NOTED WHEN THE DEVICE WAS REMOVED FROM THE ANATOMY, TO FIGURE OUT WHY IT WOULD NOT ADVANCE. ANOTHER ABSOLUTE PRO WAS USED WITHOUT ISSUE TO SUCCESSFULLY 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 12734157 ↗
• MalfunctionFeb 10, 2021Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE 7.0X80MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION OVER A .014 NON-ABBOTT GUIDE WIRE. DURING DEPLOYMENT, RESISTANCE WAS MET WITH THE THUMBWHEEL AND THE STENT COULD NOT BE DEPLOYED. THE DECISION WAS MADE TO REMOVE THE SESS HOWEVER DURING RETRACTION THE STENT PARTIALLY DEPLOYED IN THE TARGET LESION THEREFORE THE PHYSICIAN DECIDED TO CONTINUE WITH DEPLOYMENT. RESISTANCE WAS STILL MET ROTATING THE THUMBWHEEL HOWEVER THE STENT WAS ABLE TO BE COMPLETELY DEPLOYED. 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 11310975 ↗
• MalfunctionJan 15, 2021Difficult to Remove; Noise, Audible

  IT WAS REPORTED THAT A PERCUTANEOUS INTERVENTION WAS BEING PERFORMED ON THE SUPERFICIAL FEMORAL ARTERY LESION. AN ABSOLUTE PRO STENT DELIVERY SYSTEM (SDS) ADVANCED WITHOUT ISSUE TO THE LESION SITE. DURING STENT DEPLOYMENT, A STRANGE NOISE WAS HEARD, HOWEVER, THERE WAS NO ISSUE WITH DEPLOYMENT, NO UNUSUAL RESISTANCE NOTED, AND THE STENT WAS SUCCESSFULLY IMPLANTED. AFTER STENT IMPLANTATION AND DURING ABSOLUTE PRO DELIVERY SYSTEM REMOVAL, RESISTANCE WAS NOTED WITH THE WIRE. THE ABSOLUTE PRO DELIVERY SYSTEM AND WIRE WERE REMOVED AS A SINGLE UNIT. THE STENT REMAINED SUCCESSFULLY IMPLANTED AND THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11178172 ↗
• MalfunctionJan 22, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING THE INCOMING INSPECTION OF A 7.0X80MM X 135CM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM AT A DISTRIBUTOR, A PIECE OF BLACK FOREIGN MATERIAL WAS FOUND INSIDE OF THE SEALED STERILE POUCH. NO DAMAGE WAS NOTED TO THE POUCH AND DEVICE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS IDENTIFIED THE FOREIGN MATERIAL AS POTENTIAL MANUFACTURING COMPONENT.

  Patient problems: No Patient Involvement

  MAUDE report 8269125 ↗
• InjuryDec 30, 2016Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION WITH CHRONIC TOTAL OCCLUSION (CTO) LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) THAT IS HEAVILY CALCIFIED. RESISTANCE WAS NOT FELT DURING ADVANCEMENT OF THE 7.0/80 MM/135 CM ABSOLUTE PRO STENT DELIVERY SYSTEM (SDS) THROUGH LESION AND IT CROSSED SUCCESSFULLY. THE STENT WAS EXPANDED ABOUT 1/4 OF THE LENGTH WHEN THE THUMBWHEEL OF THE DEVICE BECAME STUCK AND WOULD NOT CONTINUE TO DEPLOY THE STENT. THE HANDLE WAS DISASSEMBLED IN ORDER TO MANUALLY WORK THE INTERNAL MECHANISM TO DEPLOY THE STENT SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6215769 ↗