Absolute Pro 1012532-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648175862), received between Jan 15, 2019 and May 27, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed 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. 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.

• MalfunctionMay 27, 2025Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE EXTERNAL ILIAC ARTERY. THE 10X80MM ABS PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, AFTER TWO RINGS OF THE STENT HAD BEEN RELEASED, THE THUMBWHEEL BECOME STUCK AND THEREFORE, THE STENT COULD NO LONGER BE DEPLOYED. THE SESS WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT STENT. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089307 ↗
• InjuryJul 17, 2019Stretched; Difficult or Delayed Activation; Stretched; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-CALCIFIED, MILDLY TORTUOUS COMMON ILIAC ARTERY THAT WAS 75% STENOSED. DURING DEPLOYMENT OF A 10X80MM ABSOLUTE PRO SELF-EXPANDING STENT, THE DELIVERY SYSTEM WAS ATTEMPTED TO BE PULLED BACK A LITTLE TO RE-POSITION THE STENT. HOWEVER, THE STENT BECAME STRETCHED AT 10CM AS WELL AS THE CELLS OF THE STENT IMPLANT. IT WAS NOTED THAT THE STENT WAS IMPLANTED AT THE TARGET LESION AS WELL AS IN HEALTHY TISSUE. A 7.0X40MM ABSOLUTE PRO STENT WAS ADDITIONALLY DEPLOYED IN THE STRETCHED STENT TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8800646 ↗
• 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 8248993 ↗