Absolute Pro 1012529-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648175657), received between Feb 2, 2023 and Apr 23, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A LEFT SUBCLAVIAN ARTERY. THE THUMBWHEEL OF THE 7.0X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT DELIVERY SYSTEM WAS DIFFICULT TO ROLL WHILE DEPLOYING, AND THE STENT WAS PARTIALLY DEPLOYED (FLOWERED) BUT WAS STILL ABLE TO BE REMOVED. A NEW UNSPECIFIED STENT WAS USED TO COMPLETE THE PROCEDURE. 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 24970472 ↗
• MalfunctionDec 23, 2025Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT EXTERNAL ILIAC ARTERY. A 0.035" GUIDEWIRE WAS ADVANCED. THE 7.0X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS UNLOCKED AND THE THUMBWHEEL WAS TURNED BUT WITH RESISTANCE AND THE STENT COMPLETELY FAILED TO DEPLOY. A SECOND ABSOLUTE PRO SESS WAS ATTEMPTED TO BE USED BUT SAME RESISTANCE WITH THE THUMBWHEEL AND ONLY PARTIALLY DEPLOYED. THE DEVICE WAS REMOVED AND A BALLOON WAS INSTEAD USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS OF THE FIRST 7.0X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) REVEALED THE STENT IMPLANT WAS EXPOSED 5 MM FROM THE DISTAL END OF THE SHEATH. THERE WERE SPLITS NOTED ON THE OUTER MEMBER PROXIMAL TO THE OUTER MEMBER-STENT SHEATH BOND AREA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878479 ↗
• MalfunctionDec 5, 2025Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT EXTERNAL ILIAC ARTERY. A 0.035" GUIDEWIRE WAS ADVANCED. THE 7.0X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS UNLOCKED AND THE THUMBWHEEL WAS TURNED BUT WITH RESISTANCE AND THE STENT COMPLETELY FAILED TO DEPLOY. A SECOND ABSOLUTE PRO SESS WAS ATTEMPTED TO BE USED BUT SAME RESISTANCE WITH THE THUMBWHEEL AND ONLY PARTIALLY DEPLOYED. THE DEVICE WAS REMOVED AND A BALLOON WAS INSTEAD USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. DEVICE RETURN ANALYSIS OF THE FIRST 7.0X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) REVEALED THE STENT IMPLANT WAS EXPOSED 5 MM FROM THE DISTAL END OF THE SHEATH. THERE WERE SPLITS NOTED ON THE OUTER MEMBER PROXIMAL TO THE OUTER MEMBER-STENT SHEATH BOND AREA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23733388 ↗
• MalfunctionSep 1, 2023Premature Activation; Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure; Noise, Audible; Premature Activation; Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure; Noise, Audible

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE ACCOUNT STATED THAT THE THUMBWHEEL WAS UNLOCKED AND BEING TURNING WHEN EXTRA CLICKS WERE HEARD AND THE THUMBWHEEL COULD NOT BE MOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671446 ↗
• MalfunctionFeb 2, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. DURING ADVANCEMENT OF THE 7.00X100MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS), WITHOUT RESISTANCE, THE CATHETER OF THE SESS SEPARATED INTO 3 PIECES. THE SESS STAYED ON THE WIRE AND WAS ABLE TO BE REMOVED AS A SINGLE UNIT; HOWEVER, RESISTANCE WAS NOTED WITH THE SLENDER 6FR GUIDE CATHETER DURING REMOVAL. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A SAME SIZE ABSOLUTE PRO WITH A LESS SLENDER 6FR GUIDE CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16287407 ↗