Absolute Pro 1012536-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648176159), received between Nov 29, 2018 and Mar 19, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Premature Activation

  IT WAS REPORTED THAT DURING PREPARATION WHEN LOADING THE 8X60MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM OVER THE GUIDE WIRE, IT WAS NOTED THE STENT WAS EXPOSED A COUPLE OF MILLIMETERS. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED USING ANOTHER ABSOLUTE PRO. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640831 ↗
• InjuryNov 14, 2025Premature Activation; Difficult to Advance; Mechanical Jam; Activation Failure; Premature Activation; Difficult to Advance; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH NO TORTUOSITY BUT SEVERE STENOSIS. THE 8X60 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) FAILED TO DEPLOY THE STENT AND THE HANDLE WAS TAKEN APART IN ORDER TO ATTEMPT TO DEPLOY THE STENT HOWEVER, THERE WAS DIFFICULTY AS THE VALVE WAS STUCK ON THE OUTER LINING OF THE STENT DELIVERY CATHETER. THE SYSTEM WITH THE STENT WAS ABLE TO BE REMOVED FROM THE ANATOMY AND THEN THE STENT PREMATURELY DEPLOYED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559686 ↗
• MalfunctionMay 16, 2024Premature Activation; Mechanical Jam; Activation Failure; Premature Activation; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT DURING THE PROCEDURE AN ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM WAS BEING USED TO TREAT AN EXTERNAL ILIAC LESION. HOWEVER, THE THUMBWHEEL JAMMED AND THE STENT DID NOT DEPLOY. THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER NON-ABBOTT STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS IDENTIFIED THAT THE STENT WAS EXPOSED FOR APPROXIMATELY 4MM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332367 ↗
• MalfunctionJul 8, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT AND LEFT EXTERNAL ILIAC. THE BILATERAL EXTERNAL ILIAC, COMMON ILIAC, AND THE DISTAL AORTA WERE VERY CALCIFIED. SHOCKWAVE THERAPY WAS PERFORMED. THE ABSOLUTE PRO (9090461) WAS ADVANCED HOWEVER IT WAS BELIEVED THE STENT FAILED TO DEPLOY BECAUSE THE STENT MARKERS WERE NOT VISIBLE. THE DEVICE WAS REMOVED WITHOUT ISSUE. THE SAME ISSUE OCCURRED WITH TWO OTHER ABSOLUTE PRO DEVICES (9080861, 9010261); IT WAS BELIEVED THE STENTS COMPLETELY FAILED TO DEPLOY BECAUSE THE STENT MARKERS WERE NOT VISIBLE. NO OTHER ATTEMPTS WERE MADE TO STENT. THE FILMS WERE REVIEWED, THE STENTS WERE CONFIRMED TO HAVE BEEN DEPLOYED IN THE TARGET VESSELS, HOWEVER, THE MARKERS WERE NOT VISIBLE DUE TO THE PATIENT ANATOMY. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10248283 ↗
• MalfunctionMay 6, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED, NONE TORTUOUS LEFT COMMON ILIAC ARTERY. THE 8.0X60MM ABSOLUTE PRO STENT WAS IMPLANTED. IT WAS THEN NOTED THAT THE STENT WAS SIGNIFICANTLY SHORTER THAN THE DELIVERY CATHETER MARKER LENGTH. AN ADDITIONAL UNSPECIFIED STENT WAS NEEDED TO COVER THE LESION. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10028948 ↗
• MalfunctionNov 29, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THERE WAS A PURPLE FOREIGN MATERIAL IN THE STERILE PACKAGING OF A 8.0 X 60 MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS). THERE WAS NO REPORTED DAMAGE TO THE INNER POUCH OR THE SESS. THE INCIDENT OCCURRED DURING AN INSPECTION OF A CONSIGNMENT RETURN AT THE DISTRIBUTION CENTER. THE SESS WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS IDENTIFIED THAT THE FOREIGN MATERIAL NOTED ON THE INSIDE OF THE STERILE POUCH OF THE SESS WAS A MANUFACTURING COMPONENT.

  Patient problems: No Patient Involvement

  MAUDE report 8116658 ↗