Absolute Pro 1012528-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648175541), received between Aug 16, 2018 and Nov 5, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2019Difficult to Insert; Material Separation; Material Deformation; Difficult to Insert; Material Separation; Material Deformation

  IT WAS REPORTED THAT THE 6.0X40 MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS INTENDED TO REACH THE DISTAL BASILIC VEIN. THE SESS WAS LOADED ON TO THE GUIDE WIRE WITHOUT INCIDENT, BUT IT COULD NOT ENTER THE RADIAL VEIN ACCESS SITE. A CLOSER LOOK OF THE SESS WAS TAKEN AT THAT TIME AND IT WAS NOTED THAT THE STENT STRUTS WERE MANGLED. THE SESS WAS REMOVED AND REPLACED WITH A NON-ABBOTT DEVICE. THE NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS FOUND THAT THE INNER MEMBER AND THE STENT HOLDER WERE SEPARATED 4MM PROXIMAL TO THE DISTAL MARKER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9279388 ↗
• MalfunctionSep 6, 2018Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 7.0 X 30MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS SUCCESSFULLY DEPLOYED. REPORTEDLY, AFTER THE PROCEDURE WHEN THE PACKAGING WAS BEING DISCARDED, IT WAS NOTICED THAT THE SESS WAS EXPIRED. 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 7852390 ↗
• MalfunctionAug 16, 2018Off-Label Use; Malposition of Device; Difficult to Advance; Off-Label Use; Malposition of Device; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN ARTERIOVENOUS FISTULA IN THE BASILIC VEIN WITH HEAVY TORTUOSITY. A 6.0MMX40MMX80CM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY. ON DEPLOYMENT THE STENT JUMPED. THERE WAS NO REPORTED PROBLEMS WITH THE DEPLOYMENT MECHANISM. THE STENT WAS DEPLOYED WITHIN THE TARGET LESION. NO ADDITIONAL INTERVENTION WAS REQUIRED. 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 7789685 ↗