Absolute Pro 1012538-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648176302), received between Aug 28, 2018 and Nov 19, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Break; Activation Failure; Break; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS ILIAC ARTERY THAT IS 85% STENOSED. THE ARTERY WAS BALLOONED WITH AN UNSPECIFIED BALLOON AND A 10X80MM ABSOLUTE PRO SELF-EXPANDING STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE OUTER SHEATH OF THE STENT FRACTURED AND THE STENT PARTIALLY DEPLOYED. THE DEVICE WAS REMOVED AND ANOTHER STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 23598089 ↗
• InjuryNov 25, 2023Difficult or Delayed Activation; Material Deformation; Mechanical Jam; Difficult or Delayed Activation; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE EXTERNAL ILIAC VEIN WITH NO CALCIFICATION AND NO TORTUOSITY. DURING THE PROCEDURE, THE THUMBWHEEL OF THE 10X80 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WOULD NOT ROLL BACK; HOWEVER, THE STENT WAS DEPLOYED BUT IT WAS MANGLED. THE STENT REMAINS FULLY INSIDE THE TARGET LESION. THERE WAS ADDITIONAL BALLOON DILATATION TO FULLY EXPAND THE STENT. THERE WERE NO ADVERSE PATIENT SEQUELA 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 18207622 ↗
• MalfunctionMay 19, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT ILIAC ARTERY. A 10X80MM ABSOLUTE PRO STENT WAS DEPLOYED WITHOUT ISSUE AND IT WAS THEN NOTED THAT THE STENT HAD SHORTENED. A 10X100MM ABSOLUTE PRO STENT WAS USED 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 Consequences Or Impact To Patient

  MAUDE report 10069668 ↗
• MalfunctionAug 28, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INCOMING INSPECTION AT THE DISTRIBUTION CENTER, BLACK FOREIGN MATERIAL WAS NOTED IN THE SEALED PACKAGING OF THE ABSOLUTE PRO VASCULAR STENT SYSTEM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7823658 ↗