Absolute Pro 1012535-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648176050), received between Jun 19, 2017 and Oct 18, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, HIGHLY STENOSED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 7X30MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS BEING DEPLOYED WHEN THE STENT JUMPED AND WAS ONLY PARTIALLY IMPLANTED IN THE TARGET LESION. A 7X2CM ABSOLUTE PRO SESS WAS THEN DEPLOYED TO FULLY COVER THE LESION AND COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629464 ↗
• MalfunctionDec 26, 2019Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SUPERFICIAL FEMORAL ARTERY INTERVENTION, WHILE LOADING THE ABSOLUTE PRO STENT DELIVERY SYSTEM ONTO THE GUIDE WIRE, THE GUIDE WIRE PERFORATED THE DEVICE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A DELAY IN PROCEDURE. ANOTHER SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9521288 ↗
• InjuryJun 19, 2017Inaccurate Delivery

  IT WAS REPORTED THAT AN ABSOLUTE PRO STENT DELIVERY SYSTEM ADVANCED TO THE RIGHT EXTERNAL ILIAC ARTERY WITHOUT ISSUE. DURING STENT DEPLOYMENT, THERE WAS NO ISSUE NOTED, HOWEVER THE STENT JUMPED DISTAL TO THE LESION. THE STENT WAS DEPLOYED COMPLETELY OUTSIDE THE TARGET LESION SITE REQUIRING ADDITIONAL BALLOON ANGIOPLASTY TO FULLY APPOSE THE STENT TO THE VESSEL WALL. FOLLOWING, A SHEATH WAS UNABLE TO PASS THROUGH THE DISTAL STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6649923 ↗