Absolute Pro 1012535-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648176043), received between Feb 25, 2020 and May 4, 2023 — 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.

• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PROCEDURE WAS PERFORMED TO TREAT LESIONS IN BOTH LEGS WITH A 7.0X60MM AND 7.0X20MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENTS SYSTEM (SESS) THAT WERE IMPLANTED SUCCESSFULLY. ON (B)(6) 2023, THE PATIENT EXPERIENCED SEVERE LEG PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 16872292 ↗
• MalfunctionMar 28, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE COMMON ILIAC ARTERY. THE 7.00X20MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS BEING ADVANCED TO THE TARGET LESION WHEN IT WAS NOTED THAT THE STENT COMING OUT OF THE SHEATH PRIOR TO DEPLOYMENT. THEREFORE, THE SESS WAS REMOVED FROM PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. SUBSEQUENT TO THE INITIAL REPORT BEING FILED IT WAS REPORTED THAT POST PROCEDURE THE PROCEDURE TECHNICIAN FULLY DEPLOYED THE STENT ON THE BACK TABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629172 ↗
• MalfunctionMar 26, 2021Off-Label Use; Malposition of Device; Off-Label Use; Malposition of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT CEPHALIC OUTFLOW VEIN. AN ABSOLUTE PRO WAS ADVANCED TO THE LESION WITHOUT RESISTANCE AND DEPLOYMENT WAS INITIATED. WHILE DEPLOYING THE STENT, IT JUMPED AND ONLY COVERED PART OF THE TARGET LESION. ANOTHER STENT WAS USED TO COVER THE UNCOVERED PORTION OF THE LESION. IT WAS CONFIRMED THAT THERE WAS NO ISSUE WITH THE THUMBWHEEL MECHANISM. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11577357 ↗
• MalfunctionFeb 25, 2020Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  ADDITIONAL INFORMATION: THE PROCEDURE WAS A FEMORAL TO FEMORAL CROSSOVER TO TREAT A 70% CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND RIGHT TIBIAL-PERONEAL TRUNK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9750890 ↗