Absolute Pro 1012538-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648176289), received between Jun 22, 2017 and Mar 27, 2024 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inaccurate Delivery” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2024Stretched; Difficult or Delayed Activation; Stretched; Difficult or Delayed Activation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE EXTERNAL ILIAC ARTERY. THE 10.0X40MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION AND THE STENT DEPLOYED. DURING REMOVAL OF THE SES, IT WAS NOTED THE STENT WAS NOT COMPLETELY DEPLOYED AND THEREFORE DURING RETRACTION THE IMPLANTED PORTION STRETCHED AND ELONGATED. THE STENT HAD ELONGATED INTO SOME MODERATELY DISEASED LESION THAT WAS NOT INTENDED TO BE STENTED. TWO ADDITIONAL STENTS WERE IMPLANTED TO COVER THE ELONGATED STENT. A DELAY IN THE PROCEDURE WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985333 ↗
• InjuryOct 5, 2023Difficult to Remove; Mechanical Jam; Insufficient Device Problem Information; Activation Failure; Difficult to Remove; Mechanical Jam; Insufficient Device Problem Information; Activation Failure

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS). THE STENT HAD TO BE REMOVED VIA A CUT DOWN. SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). HALFWAY THROUGH DEPLOYMENT OF THE ABSOLUTE PRO STENT, THE THUMBWHEEL GOT STUCK AND WOULD NOT ADVANCE. THE STENT WAS STUCK IN THE SHEATH WHICH PULLED IT OUT FROM THE DELIVERY CATHETER. THE PATIENT WAS HOSPITALIZED ADDITIONAL TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878052 ↗
• MalfunctionJun 15, 2022Difficult to Insert; Premature Activation; Difficult to Insert; Premature Activation

  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 14700961 ↗
• InjuryJan 11, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A LEFT SUBCLAVIAN ARTERY STENTING PROCEDURE, THE ABSOLUTE PRO STENT SYSTEM WAS ADVANCED TO THE LESION WITHOUT ISSUE; HOWEVER, DURING STENT DEPLOYMENT, THE STENT JUMPED INTO THE AORTA. THE STENT WAS SNARED AND REMOVED. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ANOTHER SAME SIZE ABSOLUTE PRO STENT WAS SUCCESSFULLY DEPLOYED AND IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION REGARDING THIS ISSUE WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11152461 ↗
• MalfunctionJul 26, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INCOMING INSPECTION AT CENTURY MEDICAL DISTRIBUTION CENTER, A PURPLE FOREIGN MATERIAL WAS NOTED IN THE STERILIZATION PACKAGING OF A 10.0 X 40 MM ABSOLUTE PRO VASCULAR STENT-EXPANDING SYSTEM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. CHEMICAL ANALYSIS REPORT CONCLUDED THE LOOSE UNKNOWN PURPLE MATERIAL IN THE HEADER BAG WAS POLYCARBONATE AND MAY HAVE COME FROM THE HANDLE PORT.

  Patient problems: No Patient Involvement

  MAUDE report 7724288 ↗
• MalfunctionFeb 22, 2018Inaccurate Delivery

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH NO CALCIFICATION IN THE RIGHT CEPHALIC VEIN. A 10.0/40 MM ABSOLUTE PRO STENT JUMPED DISTALLY DURING DEPLOYMENT. THE STENT WAS PLACED PARTIALLY IN THE LESION AND PARTIALLY IN HEALTHY TISSUE. AN ADDITIONAL NON-ABBOTT STENT WAS USED TO TREAT THE REMAINING PART OF THE LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7290891 ↗
• InjuryNov 3, 2017Improper or Incorrect Procedure or Method; Inaccurate Delivery

  IT WAS REPORTED THAT AN ABSOLUTE PRO STENT DELIVERY SYSTEM ADVANCED TO THE RIGHT CEPHALIC VEIN. DURING STENT DEPLOYMENT, THE STENT MISSED THE LESION AND JUMPED INTO HEALTHY TISSUE. A NON-ABBOTT STENT WAS IMPLANTED TO TREAT THE LESION. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7001009 ↗
• MalfunctionJun 22, 2017Inaccurate Delivery

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY TORTUOUS, DE NOVO LEFT AND RIGHT COMMON ILIAC ARTERY (CIA) THE 10X40X135MM ABSOLUTE STENT WAS ADVANCED FROM THE LEFT BRACHIAL TO THE LESION IN LEFT CIA AND A 10X40X80MM ABSOLUTE PRO STENT WAS ADVANCED FROM THE RIGHT SFA (IPSILATERAL RETROGRADE APPROACH) TO THE LESION IN RIGHT CIA. IT WAS NOTED THAT DURING DEPLOYMENT AT THE SAME TIME BOTH STENTS JUMPED NOT FULLY IN THE TARGET LESION. ONE EACH 8 X 40 MM ADDITIONAL STENT WAS USED TO FULLY COVER BOTH TARGET LESION LOCATIONS WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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 6661719 ↗