Absolute Pro 1012536-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648176128), received between Dec 9, 2016 and Jan 16, 2026 — classified as 1 injury, 4 malfunctions.

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

• MalfunctionJan 16, 2026Premature Activation; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE 8X20 MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS BEING ADVANCED ONTO A GUIDE WIRE WHEN THE DEVICE BECAME STUCK TO THE GUIDE WIRE PRIOR TO ENTERING THE SHEATH. WHEN ATTEMPTING TO SLIDE THE DEVICE FROM THE WIRE, THERE WAS RESISTANCE AND THE STENT BEGAN TO UNSHEATHE AND FLOWER. A NEW ABSOLUTE PRO SESS 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 24100122 ↗
• InjuryJun 19, 2018Inaccurate Delivery

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED EXTERNAL ILIAC ARTERY THAT DID NOT HAVE ANY TORTUOSITY. A 6.0 X 60 MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS USED AND DID NOT MEET ANY RESISTANCE DURING ADVANCEMENT. HOWEVER, THE STENT JUMPED DURING DEPLOYMENT FROM THE LESION AND INTO HEALTHY TISSUE FULLY DEPLOYED. THEREFORE, ANOTHER UNSPECIFIED ABSOLUTE PRO VASCULAR STENT WAS IMPLANTED IN THE LESION TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7614478 ↗
• MalfunctionApr 16, 2018Inaccurate Delivery

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. A 8.0 X 20 MM ABSOLUTE PRO VASCULAR STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT ISSUE TO THE LESION. DURING DEPLOYMENT OF THE STENT, THE STENT JUMPED FORWARD ONLY PARTIALLY COVERING THE LESION. NO FURTHER TREATMENT WAS PERFORMED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7434938 ↗
• MalfunctionMar 23, 2017Inaccurate Delivery

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ILIAC ARTERY WITH NO CALCIFICATION AND NO TORTUOSITY. RESISTANCE WAS NOT FELT DURING ADVANCEMENT OF THE 8.0 X 20 MM ABSOLUTE PRO STENT DELIVERY SYSTEM (SDS) AND IT CROSSED THE LESION SUCCESSFULLY; HOWEVER, DURING DEPLOYMENT OF THE STENT, THE PHYSICIAN NOTED THAT THE STENT JUMPED FORWARD SLIGHTLY. STENT WAS DEPLOYED PARTIALLY IN HEALTH TISSUE; HOWEVER, COVERED MOST THE LESION THEREFORE NO ADDITIONAL STENT WAS NEEDED. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6430433 ↗
• MalfunctionDec 9, 2016Premature Activation

  IT WAS REPORTED THAT AN 8.0 X 20 MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM HAD WRITTEN ON THE BOX PARTIALLY EXPANDED. ANOTHER ABSOLUTE PRO WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE IS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6159433 ↗