Absolute Pro 1012532-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648175879), received between Nov 16, 2017 and Sep 17, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Difficult to Advance; Mechanical Jam; Activation Failure; Difficult to Advance; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY THAT IS 75% STENOSED. DURING ADVANCEMENT OF 10X100MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM RESISTANCE WAS FELT WITH A .035 UNSPECIFIED GUIDE WIRE AS THE GUIDE WIRE WAS NOT WET ENOUGH. WHEN ATTEMPTING TO DEPLOY THE STENT THE THUMBWHEEL WAS NOTE TO BE DIFFICULT TO TURN; HOWEVER, THE STENT WAS DEPLOYED. WHEN ATTEMPTING TO REMOVE THE STENT DELIVERY SYSTEM IT WAS OBSERVED THAT THE STENT WAS BEING PULLED BACK, WHICH 80% OF THE STENT WAS PULLED BACK IN THE SHEATH AND REMOVED. ANOTHER SAME SIZE ABSOLUTE PRO WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 23078535 ↗
• MalfunctionSep 2, 2025Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  SUBSEQUENTLY, AFTER THE INITIAL REPORT WAS FILED, THE DEVICE RECEIVED AND DETERMINED TO BE A 10.0X100MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22933260 ↗
• InjuryJun 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, AFTER ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS), ASPIRATION THROMBECTOMY WAS PERFORMED. AN ABSOLUTE PRO STENT WAS PLACED IN THE RIGHT COMMON ILIAC ARTERY AND A SUPERA SELF EXPANDING STENT (SES) WAS PLACED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. TWO NON-ABBOTT STENTS WERE ALSO PLACED IN THE RIGHT LEG. ON (B)(6) 2019, NO PULSE COULD BE IDENTIFIED ON THE PATIENT'S RIGHT LEG SO AN ANGIOGRAPHY WAS PERFORMED THAT CONFIRMED ACUTE THROMBOTIC OCCLUSION IN THE SUPERA AND ABSOLUTE PRO STENTS. THERE WAS NO TREATMENT PERFORMED. REPORTEDLY, THE OTHER NON-ABBOTT STENTS SIMILARLY RESULTED IN ACUTE THROMBUS OCCLUSION. NO TREATMENT WAS PERFORMED; HOWEVER, BYPASS IS SCHEDULED IN THE FUTURE. THE PATIENT OUTCOME IS REPORTED AS "NOT RECOVERED". NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Diminished Pulse Pressure; Thrombosis

  MAUDE report 8666785 ↗
• MalfunctionNov 2, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INCOMING INSPECTION OF AN 10X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) A SMALL PIECE OF WHITE FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE POUCH. THE INNER POUCH WAS INTACT AND THE STERILITY OF THE DEVICE WAS NOT COMPROMISED. 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.

  Patient problems: No Patient Involvement

  MAUDE report 8035432 ↗
• MalfunctionOct 12, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INCOMING INSPECTION OF AN 10X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) A SMALL PIECE OF WHITE FOREIGN PARTICLE WAS INSIDE THE STERILE POUCH. THE INNER POUCH WAS INTACT AND THE STERILITY OF THE DEVICE WAS NOT COMPROMISED. 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.

  Patient problems: No Patient Involvement

  MAUDE report 7962900 ↗
• InjuryNov 16, 2017Difficult or Delayed Positioning; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A CONCENTRIC, DE NOVO LESION WITH NO TORTUOSITY LOCATED DIRECTLY UNDER THE BIFURCATION TO EXTERNAL ILIAC ARTERY, THE LESION LENGTH WAS 140 MM. A 10 X 100 MM ABSOLUTE PRO STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION AND DEPLOYMENT WAS STARTED, BUT DURING THE ATTEMPT TO POSITION THE STENT, WHILE PULLING BACK THE DELIVERY SYSTEM, THE STENT GOT CAUGHT WITH BIFURCATION, WHICH STRETCHED THE STENT. THE STRETCHED STENT WAS IMPLANTED AT THE TARGET LESION AND AN ADDITIONAL PLANNED 9 X 60 MM ABSOLUTE PRO STENT WAS USED TO COVER THE REST OF THE LONG LESION. A 10.0 MM NON-ABBOTT STENT WAS IMPLANTED TO COVER THE STRETCHED PART OF THE STENT. THE PROCEDURE WAS COMPLETED. THERE WAS 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 7038099 ↗