Absolute Pro 1012530-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648175725), received between Aug 21, 2018 and Apr 6, 2023 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2023Difficult to Remove; Mechanical Jam; Activation Failure; Difficult to Remove; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR ILIAC STENT PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE ILIAC ARTERY WITH NO CALCIFICATION, NO TORTUOSITY AND 70% STENOSIS. THE 8.0X80MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION. DURING DEPLOYMENT, THE STENT PARTIALLY DEPLOYED IN THE INTRODUCER SHEATH AND THE THUMBWHEEL WOULDN¿T MOVE. THE STENT WAS THOUGHT TO BE FULLY DEPLOYED IN THE VESSEL UNDER FLUOROSCOPY; HOWEVER, WHEN THE CATHETER WAS BEING REMOVED, RESISTANCE WAS MET WITH THE INTRODUCER SHEATH AS WELL AS WITH THE GUIDE WIRE AND THE STENT. THE CATHETER WAS REMOVED. WHEN THE WIRE WAS ATTEMPTED TO BE REMOVED, THE WIRE DID NOT WANT TO COME OUT OF THE SHEATH. THE WIRE AND SHEATH WERE REMOVED, AND IT WAS FOUND THAT THE STENT WAS ATTACHED TO THE SHEATH AND WAS ALSO REMOVED. ANOTHER 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 16694143 ↗
• InjuryFeb 20, 2023Difficult to Remove; Stretched; Mechanical Jam; Activation Failure; Difficult to Remove; Stretched; Mechanical Jam; Activation Failure

  SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS REPORTED THAT THE THUMBWHEEL MAY HAVE BEEN JAMMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406077 ↗
• InjuryJul 12, 2021Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY CALCIFIED, NON-TORTUOUS ILIAC ARTERY. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON AND AN UNSPECIFIED 7F SHEATH. A 8X80MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) FAILED TO CROSS DUE TO THE ANATOMY. DURING REMOVAL, THE SESS FELT RESISTANCE WITH THE SHEATH, SO THE DEVICES WERE BEING REMOVED TOGETHER WHEN IT WAS NOTED THAT A PORTION OF THE STENT HAD SEPARATED AT THE ACCESS SITE. A CUT DOWN WAS PERFORMED TO REMOVE THE SEPARATED STENT PORTION, AND A SAME SIZED ABSOLUTE PRO STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS FINE. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12151247 ↗
• MalfunctionDec 21, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LEFT EXTERNAL ILIAC ARTERY. AN 8.0X80MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT (SES) SYSTEM WAS ADVANCED TO THE LESION AND DEPLOYMENT INITIATED. WHEN THE STENT WAS HALFWAY DEPLOYED, THE DEPLOYMENT SYSTEM BECAME STUCK, SO THE HANDLE WAS ROTATED WHICH UNLOCKED THE SYSTEM AND THE STENT WAS ABLE TO BE FULLY DEPLOYED. 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 11051381 ↗
• InjuryNov 8, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THIS WAS A PROCEDURE PERFORMED TO TREAT A CHRONIC TOTAL OCCLUSION IN THE RIGHT ILIAC ARTERY. PATIENT ANATOMY INCLUDED TWO PREVIOUSLY IMPLANTED STENTS. PRE DILATATION WAS PERFORMED AND AN 8X80 ABSOLUTE PRO VASCULAR STENT WAS IMPLANTED WITHOUT ISSUE. A SECOND ABSOLUTE PRO VASCULAR STENT WAS IMPLANTED PROXIMALLY, OVERLAPPING THE FIRST STENT, AND ROUTINE POST DILATATION WAS PERFORMED. IT WAS NOTED THAT THE 8X80 STENT APPEARED MISSHAPEN, AS IF IT WAS BULGING OUT AND IT WAS OBSERVED THAT A PERFORATION OCCURRED, WITH THE STENT EXTENDING OUTSIDE THE PERFORATED ARTERY. MASSIVE HEMORRHAGE WAS SEEN, AND A NON-ABBOTT COVERED STENT WAS IMPLANTED TO SEAL THE PERFORATION; HOWEVER, THE BLEEDING CONTINUED. A DISSECTION WAS NOTED OUTSIDE THE STENTED AREA. PROLONGED BALLOON DILATATION WAS PERFORMED, AND THE PATIENT WAS AIR-LIFTED TO A SECOND FACILITY. A SURGICAL PROCEDURE WAS PERFORMED TO REPAIR THE ILIAC ARTERY. THE NON-ABBOTT COVERED STENT REMAINED PATENT AND NO ADDITIONAL INTERVENTION WAS PERFORMED, RELATED TO THE ISSUE WITH THE ABSOLUTE PRO VASCULAR STENT. POST SURGICAL PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 9301474 ↗
• InjuryAug 21, 2018Premature Activation; Mechanical Jam; Activation Failure; Premature Activation; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED RIGHT EXTERNAL ILIAC ARTERY THAT DID NOT HAVE ANY TORTUOSITY. THE ACCESS POINT WAS THE LEFT COMMON FEMORAL ARTERY AND THEY USED A 6 FRENCH SHEATH. THEY ADVANCED THE FIRST 8.0 X 80 MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT (SES) SYSTEM TO THE LESION. THE DEVICE WAS THEN UNLOCKED; HOWEVER, THE THUMBWHEEL WOULD NOT TURN. THEREFORE, THE DEVICE WAS REMOVED FROM THE ANATOMY AND ANOTHER 8.0 X 80 MM ABSOLUTE PRO VASCULAR SES WAS ADVANCED TO THE LESION. HOWEVER, THE SAME ISSUE OCCURRED WITH THE THUMBWHEEL. THE DEVICE WAS THEN REMOVED FROM THE ANATOMY AND A 8.0 X 80 MM 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. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS NOT RETURNED WITH THE DEVICE AND THEREFORE, IT MAY HAVE BEEN DEPLOYED IN THE PATIENT ANATOMY.

  Patient problems: Foreign Body In Patient

  MAUDE report 7802584 ↗
• InjuryAug 21, 2018Premature Activation; Mechanical Jam; Activation Failure; Premature Activation; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED RIGHT EXTERNAL ILIAC ARTERY THAT DID NOT HAVE ANY TORTUOSITY. THE ACCESS POINT WAS THE LEFT COMMON FEMORAL ARTERY AND THEY USED A 6 FRENCH SHEATH. THEY ADVANCED THE FIRST 8.0 X 80 MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT (SES) SYSTEM TO THE LESION. THE DEVICE WAS THEN UNLOCKED; HOWEVER, THE THUMBWHEEL WOULD NOT TURN. THEREFORE, THE DEVICE WAS REMOVED FROM THE ANATOMY AND ANOTHER 8.0 X 80 MM ABSOLUTE PRO VASCULAR SES WAS ADVANCED TO THE LESION. HOWEVER, THE SAME ISSUE OCCURRED WITH THE THUMBWHEEL. THE DEVICE WAS THEN REMOVED FROM THE ANATOMY AND A 8.0 X 80 MM 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. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS NOT RETURNED WITH THE DEVICE AND THEREFORE, IT MAY HAVE BEEN DEPLOYED IN THE PATIENT ANATOMY.

  Patient problems: Foreign Body In Patient

  MAUDE report 7802541 ↗