Absolute Pro 1012532-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648175855), received between Jan 15, 2019 and Apr 8, 2024 — classified as 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2024Difficult to Remove; Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure; Difficult to Remove; Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE EXTERNAL ILIAC ARTERY WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. THE 10X60MM ABSOLUTE VASCULAR PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION USING THE CROSSOVER APPROACH ON A .018 GUIDE WIRE. DURING STENT DEPLOYMENT THE THUMBWHEEL BECAME STUCK AFTER 1 CLICK AND THE STENT WAS ONLY ABLE TO BE PARTIALLY DEPLOYED. A .014 GUIDE WIRE WAS ADVANCED IN AN ATTEMPT TO STRAIGHTEN THE VERY TORTUOUS ANATOMY; HOWEVER, THE THUMBWHEEL REMAINED JAMMED. THE INTRODUCER SHEATH WAS PUSHED FORWARD TO COLLAPSE THE DEPLOYED STENT AND THE SESS WITH THE STENT WAS REMOVED FROM THE ANATOMY. IN THE PHYSICIAN'S OPINION, THE THUMBWHEEL BECAME STUCK DUE TO PATIENT'S VERY TORTUOUS ANATOMY. ANOTHER ABSOLUTE PRO STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068160 ↗
• MalfunctionJan 15, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE COMMON ILIAC. THE 10X80MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION HOWEVER THE STENT WAS DIFFICULT TO DEPLOY. A 10X60MM ABSOLUTE PRO VASCULAR WAS ADVANCED AND WAS ALSO DIFFICULT TO DEPLOY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8249076 ↗