Absolute Pro 1012531-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648175787), received between May 12, 2017 and Apr 1, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Improper or Incorrect Procedure or Method; Difficult to Advance; Mechanical Jam; Activation Failure; Improper or Incorrect Procedure or Method; Difficult to Advance; Mechanical Jam; Activation Failure

  RETURNED DEVICE ANALYSIS FOUND THAT A PARTIAL SEPARATION WAS NOTED AT THE OUTER MEMBER-STENT SHEATH BOND AREA. A .014 UNSPECIFIED GUIDE WIRE WAS USED WITH THE ABSOLUTE PRO. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21746224 ↗
• InjuryDec 23, 2020Break; Break

  IT WAS REPORTED THAT A 9.0X40MM ABSOLUTE VASCULAR PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION, AND THE STENT WAS SUCCESSFULLY DEPLOYED. THE STENT WAS POST-DILATED WITHOUT ISSUES; HOWEVER, A STENT FRACTURE ON THE DISTAL END WAS OBSERVED. ANOTHER 9.0X40MM ABSOLUTE VASCULAR PRO STENT WAS DEPLOYED OVERLAPPING TO TREAT THE FRACTURED STENT. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11069896 ↗
• MalfunctionDec 16, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT EXTERNAL ILIAC ARTERY. A 9.0X40MM ABSOLUTE PRO SELF-EXPANDING STENT WAS DEPLOYED WITHOUT ISSUES; HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM RESISTANCE WITH THE INTRODUCER SHEATH WAS FELT. THE DELIVERY SYSTEM AND INTRODUCER SHEATH WERE REMOVED AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 9476338 ↗
• InjuryOct 20, 2017Difficult or Delayed Positioning; Inaccurate Delivery

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE NON-TORTUOUS, MODERATELY CALCIFIED 70% STENOSED, PROXIMAL LEFT EXTERNAL ILIAC ARTERY. A 9.0 X 40 MM ABSOLUTE PRO VASCULAR STENT DELIVERY SYSTEM (SDS) WAS SELECTED FOR THE PROCEDURE. THE SDS WAS ADVANCED TO THE LESION AND DURING DEPLOYMENT OF THE STENT IMPLANT, THE THUMBWHEEL STOPPED TURNING AND THEY DECIDED TO REMOVE THE SDS FROM THE ANATOMY. WHEN THEY PULLED THE SDS BACK INTO THE SHEATH THE STENT DEPLOYED AT THE AORTIC BIFURCATION INSTEAD OF THE PROXIMAL LEFT EXTERNAL ILIAC AS INTENDED. THE STENT WAS LEFT IN PLACE AND A OMNILINK STENT WAS IMPLANTED IN THE PROXIMAL LEFT EXTERNAL ILIAC TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6966293 ↗
• MalfunctionMay 12, 2017Device Expiration Issue; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ILIAC. AFTER THE ABSOLUTE PRO SELF-EXPANDING STENT WAS IMPLANTED, IT WAS DISCOVERED THAT THE PRODUCT HAD EXPIRED FOUR DAYS BEFORE IMPLANT DATE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6565231 ↗