Absolute Pro 1012538-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648176296), received between Sep 14, 2017 and Sep 10, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2024Stretched; Material Deformation; Stretched; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE AV FISTULA. THE 10X60MM ABS PRO SELF EXPANDING STENT SYSTEM (SESS) WAS IMPLANTED AT THE TARGET LESION WITHOUT ISSUE. HOWEVER, AFTER POST DILATATION THE STENT APPEARED TO HAVE SLIGHTLY ELONGATED AND A BUCKLE APPEARED AT A TURN IN THE ARTERY WALL AT A SIDE BRANCH AT THE TARGET LESION. ALTHOUGH, THERE WAS NO ISSUE WITH FLOW OR PATIENT EFFECT, OUT PRECAUTION THE PHYSICIAN DECIDED TO IMPLANT A COVERED STENT IN THE MIDDLE OF THE IMPLANTED ABS PRO STENT TO ENSURE THE STENT WAS ADHERED TO THE VESSEL. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185353 ↗
• MalfunctionMar 26, 2024Difficult to Remove; Material Separation; Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult to Remove; Material Separation; Difficult or Delayed Activation; Physical Resistance/Sticking

  SUBSEQUENT TO THE INITIALLY FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT DURING RETRACTION OF THE SES, THE TIP SEPARATED AND BECAME LODGED IN THE SHEATH. THE SEPARATED TIP WAS REMOVED WITH THE SHEATH AND GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977818 ↗
• MalfunctionDec 30, 2019Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED THAT THE 10 X 60 MM ABSOLUTE PRO VASCULAR STENT WAS UNABLE TO CROSS THE MODERATELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. DURING REMOVAL OF THE SELF-EXPANDING STENT SYSTEM (SESS), SOME OF THE STENT BECAME PARTIALLY DEPLOYED/FLOWERED. NO ATTEMPT HAD BEEN MADE TO DEPLOY THE STENT AS IT HAD NOT REACHED THE TARGET LESION. THE PHYSICIAN WAS ABLE TO NORMALLY REMOVE THE SESS ALONG WITH THE PARTIALLY DEPLOYED STENT. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9530409 ↗
• MalfunctionNov 4, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT OF A 10X60MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS UNSHEATHED/EXPOSED TO THE SHEATH WHEN REMOVED FROM THE PACKAGING. THE SESS WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 10X60MM ABSOLUTE PRO SESS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9273880 ↗
• InjurySep 14, 2017Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE 10 X 60 MM ABSOLUTE PRO VASCULAR STENT SYSTEM WAS ADVANCED TO THE MILDLY TORTUOUS LEFT COMMON ILIAC ARTERY AND WAS READY FOR STENT DEPLOYMENT, BUT RESISTANCE WAS FELT WITH THE THUMBWHEEL AFTER THE FIRST QUARTER OR HALF TURN OF THE THUMBWHEEL. TROUBLESHOOTING STEPS WERE PERFORMED TO DEPLOY THE STENT, BUT RESISTANCE WAS FELT WITH THE THUMBWHEEL. THE STENT WAS DEPLOYED IN THE NON-TARGET EXTERNAL ILIAC INSTEAD OF THE INTENDED COMMON ILIAC ARTERY. A SECOND SAME SIZE ABSOLUTE PRO VASCULAR STENT WAS SUCCESSFULLY DEPLOYED IN THE TARGET LESION WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6867255 ↗