Absolute Pro 1012531-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648175794), received between Apr 10, 2017 and Nov 20, 2025 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE EXTERNAL ILIAC ARTERY. THE 9.0X60MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER DIFFICULTY WAS MET WITH THE THUMBWHEEL AND THE STENT WOULD NOT DEPLOY. THE SES WAS REMOVED AND THE PROCEDURE COMPLETED USING AN OMNILINK STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE OUTER MEMBER-STENT SHEATH BOND WAS PARTIALLY SEPARATED. THERE WERE SPLITS NOTED ON THE OUTER MEMBER PROXIMAL TO THE OUTER MEMBER-STENT SHEATH BOND AREA. THE STENT IMPLANT WAS EXPOSED 6 MM FROM THE DISTAL END OF THE SHEATH. THE DISTAL SHEATH WAS RETRACTED, 12 MM FROM THE BASE OF THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606122 ↗
• InjuryJun 27, 2025Break; Premature Activation; Difficult to Remove; Material Separation; Mechanical Jam; Activation Failure; Break; Premature Activation; Difficult to Remove; Material Separation; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE ILIAC ARTERY. A 9X60MM ABSOLUTE PRO SELF-EXPANDING STENT (SES) WAS ATTEMPTED TO BE DEPLOYED OVER A .035" NON-ABBOTT GUIDEWIRE AND THROUGH A 7F NON-ABBOTT SHEATH; HOWEVER THE SES WAS NOTED TO PARTIALLY FAIL TO DEPLOY DUE TO A MECHANICAL JAM WITH THE THUMBWHEEL, AND THE DELIVERY CATHETER [SHAFT] WAS NOTED TO CRACK. THE SES WAS ATTEMPTED TO BE WITHDRAWN, BUT AFTER RESISTANCE WAS FELT WITH THE SHEATH THE STENT WAS INADVERTENTLY DEPLOYED AND SEPARATED INSIDE THE ANATOMY. THE SMALLER PORTION OF THE SEPARATED STENT WAS NOTED TO MIGRATE TO THE LOWER AORTA IN WHICH A NON-ABBOTT STENT WAS DEPLOYED TO EMBED THE STENT TO THE VESSEL WELL. THE LARGER PORTION OF THE SEPARATED STENT WAS NOTED TO MIGRATE TO THE COMMON ILIAC ARTERY WHERE A 10MM ABSOLUTE PRO WAS DEPLOYED TO EMBED THE STENT TO THE VESSEL WALL ADN TREAT THE TARGET LESION A CLINICAL DELAY WAS NOTED AND THERE WERE NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22347232 ↗
• InjuryDec 10, 2020Difficult to Remove; Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult to Remove; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TORTUOUS EXTERNAL ILIAC ARTERY. A 9.0X60MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITH A .035 UNSPECIFIED GUIDE WIRE AND UPON ATTEMPTING TO DEPLOY THE THUMBWHEEL WOULD NOT ADVANCE; HOWEVER, THE STENT WAS PARTIALLY DEPLOYED. DURING REMOVAL THE STENT MET RESISTANCE WITH ANATOMY AND THE DEVICE FULLY DEPLOYED. THE STENT REMAINS IMPLANTED IN HEALTHY TISSUE, BUT NOT AT THE INTENDED SITE. THE SESS AND SHEATH WERE REMOVED AND ANOTHER UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10984154 ↗
• 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 10248302 ↗
• InjuryDec 13, 2019Difficult to Remove; Material Separation; Deformation Due to Compressive Stress; Difficult to Advance; Material Deformation; Difficult to Remove; Material Separation; Deformation Due to Compressive Stress; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE NON-CALCIFIED, MILDLY TORTUOUS RIGHT EXTERNAL ILIAC ARTERY. THE 9X60MM ABSOLUTE PRO STENT [SELF-EXPANDING STENT SYSTEM (SESS)] KINKED, AND THE STENT [SESS] WAS UNABLE TO BE REMOVED. AN UNSPECIFIED BALLOON DILATATION CATHETER WAS USED TO FRACTURE [SEPARATE] THE STENT. AN UNSPECIFIED STENT WAS USED IN THE SEPARATED STENT. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9465673 ↗
• InjuryOct 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, TWO ABSOLUTE PRO STENTS WERE IMPLANTED WITHOUT REPORTED ISSUE IN THE PATIENT'S GROIN AREA. SINCE IMPLANTATION, THE PATIENT HAS BEEN ITCHING AND HAS A SWOLLEN FACE. THE PATIENT HAS NOT EXPERIENCED ANY DIFFICULTY BREATHING. THE PATIENT WAS HOSPITALIZED TWICE FOR THE ALLERGIC REACTION AND MEDICATION BENADRYL AND STEROIDS WERE PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling

  MAUDE report 7936313 ↗
• InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, TWO ABSOLUTE PRO STENTS WERE IMPLANTED WITHOUT REPORTED ISSUE IN THE PATIENT'S GROIN AREA. SINCE IMPLANTATION, THE PATIENT HAS BEEN ITCHING AND HAS A SWOLLEN FACE. THE PATIENT HAS NOT EXPERIENCED ANY DIFFICULTY BREATHING. THE PATIENT WAS HOSPITALIZED TWICE FOR THE ALLERGIC REACTION AND MEDICATION BENADRYL AND STEROIDS WERE PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling

  MAUDE report 7932526 ↗
• InjuryJun 6, 2018Detachment Of Device Component; Positioning Failure; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY CALCIFIED, HEAVILY TORTUOUS, RIGHT EXTERNAL ILIAC WITH A ABSOLUTE PRO VASCULAR STENT. ACCESS WAS THROUGH THE LEFT COMMON FEMORAL ARTERY USING AN UP AND OVER TECHNIQUE. PRE-DILATATION WITH THE BALLOON DID NOT FULLY EXPAND THE HEAVILY CALCIFIED LESION AND THERE WAS A STEEP CARINA DUE TO TORTUOSITY. DURING STENT DEPLOYMENT, APPROXIMATELY 1/3 OF THE STENT DEPLOYED EASILY, BUT THEN THE SYSTEM LOCKED UP AND THE STENT COULD NOT BE DEPLOYED ANY FURTHER. THE DECISION WAS MADE TO REMOVE THE DELIVERY SYSTEM; HOWEVER, IN THE PROCESS OF REMOVAL, DUE TO RESISTANCE FELT, THE STENT IMPLANT FRACTURED LEAVING PART IN THE RIGHT ILIAC AND PART IN THE LEFT ILIAC ARTERY. TWO STENTS WERE DEPLOYED OVER EACH SEGMENT OF THE FRACTURED STENT PINNING THE FRACTURE STENT PIECES TO THE VESSEL WALL. THE STENTS ALSO SERVED TO COVER THE INTENDED LESION TREATING THE LESION. THE PATIENT IS REPORTED TO BE STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7574463 ↗
• InjuryApr 10, 2017Difficult To Position

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. AFTER POSITIONING A 6FR NON-ABBOTT GUIDING SHEATH, A 7.0MM X 40MM X 135CM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED VIA THE LEFT COMMON FEMORAL ARTERY, UP AND OVER TO THE TARGET LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. THE ABSOLUTE PRO STENT WAS DIFFICULT TO VISUALIZE UNDER FLUOROSCOPY AND THOUGHT TO BE POSITIONED IN THE TARGET LESION; WHEN RELEASING THE STENT, IT WAS DISCOVERED THAT THE PROXIMAL HALF OF THE STENT HAD RELEASED INSIDE OF THE GUIDING SHEATH. THE SHEATH, GUIDE WIRE, AND PARTIALLY DEPLOYED STENT WERE WITHDRAWN AS A SINGLE UNIT, WITH RESISTANCE FELT BUT NO VESSEL DAMAGE NOTED. HOWEVER, WHEN REACHING THE LEFT COMMON FEMORAL ARTERY, THE PORTION OF THE ABSOLUTE PRO STENT THAT WAS PROTRUDING BROKE OFF / SEPARATED IN THE VESSEL. THE SEPARATED STENT PORTION WAS SUCCESSFULLY SURGICALLY REMOVED AND TREATMENT OF THE TARGET LESION WAS RESCHEDULED FOR (B)(6) 2017. THE PATIENT RETURNED FOR TREATMENT OF THE TARGET LESION ON 23 MARCH 2017. A 9.0MM X 60MM X 80CM ABSOLUTE PRO VASCULAR SESS WAS ADVANCED VIA THE RIGHT COMMON FEMORAL ARTERY. THIS ABSOL

  Patient problems: Foreign Body In Patient

  MAUDE report 6476316 ↗