Absolute Pro 1012535-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648176074), received between May 22, 2018 and Nov 10, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) AND THERE WAS TORTUOSITY NOTED IN THE ILIAC ARTERY. THE ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION BUT THE THUMBWHEEL BECAME STUCK DURING DEPLOYMENT. WHEN REMOVING THE DELIVERY SYSTEM, THE STENT STARTED TO DEPLOY AND WAS FLOWERED BUT REMOVAL WAS PERFORMED WITHOUT ISSUE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 23510711 ↗
• MalfunctionMay 6, 2025Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY TORTUOSITY AND CALCIFICATION. ORBITAL ATHERECTOMY WAS PERFORMED. THE 7X60 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) FAILED TO DEPLOY AND THE THUMBWHEEL WOULD NOT TURN AT ALL. THE STENT WAS NOT EXPOSED. THE DEVICE WAS REMOVED FROM THE ANATOMY, AND WHEN REMOVED FROM THE SHEATH, THE STENT EXPANDED WITH NO MANIPULATION. THE 6X60 ABSOLUTE PRO SESS WAS ADVANCED. THE DEVICE PARTIALLY DEPLOYED INSIDE THE ANATOMY AND THEN ONCE OUTSIDE, IT FULLY DEPLOYED WITH NO MANIPULATION. A NON-ABBOTT BALLOON EXPANDABLE STENT WAS USED TO COMPLETE THE PROCEDURE. 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 21971906 ↗
• MalfunctionNov 26, 2024Malposition of Device; Material Deformation; Malposition of Device; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT INTERNAL ILIAC ARTERY. THE 7X60MM ABS PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET AND THE STENT WAS DEPLOYED; HOWEVER, THE STENT JUMPED SLIGHTLY DISTAL. THE STENT WAS IMPLANTED AND ADHERED TO THE VESSEL WALL BUT APPEARED SLIGHTLY BUNCHED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A 7X40MM ABS PRO STENT WAS IMPLANTED PROXIMAL TO THE INITIAL STENT TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780945 ↗
• MalfunctionJul 21, 2023Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. RESISTANCE WAS MET DURING ADVANCEMENT OF THE ABSOLUTE PRO VASCULAR STENT SYSTEM THROUGH THE SHEATH, AND THE SHAFT SEPARATED IN TWO PIECES. THEREFORE THEY ATTEMPTED TO REMOVE THE DEVICE, BUT IT BECAME STUCK IN THE SHEATH. THE ABSOLUTE PRO AND SHEATH WERE REMOVED TOGETHER WITH NO ISSUES. 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 17374598 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6)2023, THE PROCEDURE WAS PERFORMED TO TREAT LESIONS IN BOTH LEGS WITH A 7.0X60MM AND 7.0X20MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENTS SYSTEM (SESS) THAT WERE IMPLANTED SUCCESSFULLY. ON (B)(6)2023, THE PATIENT EXPERIENCED SEVERE LEG PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 16872289 ↗
• MalfunctionMay 6, 2022Difficult to Remove; Mechanical Jam; Activation Failure; Difficult to Remove; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CALCIFIED LEFT COMMON ILIAC ARTERY. WHEN ATTEMPTING TO DEPLOY THE 7.0X60MMX135CM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS), RESISTANCE WAS FELT WITH THE THUMBWHEEL. FLUOROSCOPY CONFIRMED, THE STENT WAS NOT DEPLOYING, CONFIRMED IT HAD NOT FLOWERED EITHER. THE DECISION WAS MADE TO REMOVE THE ABSOLUTE PRO, WHEN RETRACTING THE SYSTEM FROM THE SHEATH, THE DEVICE GOT CAUGHT ON THE HEMOSTATIC VALVE OF THE SHEATH AND THE STENT WAS PULLED OUT AND IS STUCK IN THE VALVE OF THE SHEATH. A NEW SHEATH AND A NON-ABBOTT STENT WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14299214 ↗
• MalfunctionAug 28, 2020Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVY CALCIFIED LESION IN THE ILIAC ARTERY. A 7.0X60MM ABSOLUTE SESS WAS ADVANCED AND SUCCESSFULLY DEPLOYED; HOWEVER THE THUMBWHEEL HAD MINOR RESISTANCE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10467491 ↗
• MalfunctionDec 18, 2019Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND CALCIFIED LESION IN THE LEFT EXTERNAL ILIAC ARTERY. THE 7.0X60MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITHOUT RESISTANCE TO THE LESION. DURING DEPLOYMENT, RESISTANCE WAS MET ROTATING THE THUMBWHEEL, RESULTING IN DIFFICULTIES DEPLOYING THE STENT. THE THUMBWHEEL AND SHAFT HAD TO BE TORQUED IN ORDER TO COMPLETELY DEPLOY THE STENT. 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 9489614 ↗
• MalfunctionAug 8, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE 7.0X60MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM WAS ADVANCED WITHOUT RESISTANCE; HOWEVER, IT WAS NOTED THAT THE STENT STARTED TO DEPLOY PRIOR TO REACHING THE TARGET LESION. THE DEVICE WAS RETRACTED WITH NO ISSUE AND REPLACED WITH ANOTHER STENT 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 7765488 ↗
• InjuryMay 22, 2018Difficult or Delayed Positioning; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A CONTRALATERAL APPROACH WAS USED TO ADVANCE THE ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) TO THE TARGET LESION. DURING DEPLOYMENT, RESISTANCE WAS MET ADVANCING THE THUMBWHEEL AND THE STENT COULD NOT BE FULLY DEPLOYED. THE HANDLE WAS OPENED AND THE STENT WAS ABLE TO BE MANUALLY DEPLOYED IN THE TARGET LESION. 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 7534340 ↗