Absolute Pro 1012528-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648175572), received between May 22, 2020 and Jun 9, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2020Premature Activation; Deformation Due to Compressive Stress; Activation Failure; Premature Activation; Deformation Due to Compressive Stress; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE PATIENT WAS HEPARINIZED AND A SHORT 6FR SHEATH WAS PLACED AT THE PEDAL ACCESS SITE. THE FIRST 6.0X100 ABSOLUTE PRO STENT WAS ATTEMPTED TO BE DEPLOYED BUT THE SHEATH OF THE STENT KINKED. THE STENT DID NOT DEPLOYED AT ALL. A NEW, SAME SIZE, ABSOLUTE PRO STENT WAS ADVANCED AND THE STENT PARTIALLY DEPLOYED FROM THE SHEATH. THE STENT WAS ABLE TO BE REMOVED, ALTHOUGH IT WAS DAMAGED. A NEW ABSOLUTE PRO STENT WAS ABLE TO BE SUCCESSFULLY DEPLOYED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE FIRST 6.0X100 ABSOLUTE PRO STENT WAS PARTIALLY EXPOSED FOR A LENGTH OF 1MM. THE SECOND ABSOLUTE PRO STENT WAS NOTED TO HAVE SEPARATED STRUTS AT THE DISTAL END OF THE STENT AND THE SEPARATED PORTION WAS NOT RETURNED. CONTACT WITH THE ACCOUNT CONFIRMED THAT THE STENT DID SEPARATE AND WAS REMOVED IN PIECES BY SNARE. THE PIECES WERE DISCARDED AND NONE WERE LEFT IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10136151 ↗
• InjuryMay 22, 2020Material Separation; Material Deformation; Activation Failure; Material Separation; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE PATIENT WAS HEPARINIZED AND A SHORT 6FR SHEATH WAS PLACED AT THE PEDAL ACCESS SITE. THE FIRST 6.0X100 ABSOLUTE PRO STENT WAS ATTEMPTED TO BE DEPLOYED BUT THE SHEATH OF THE STENT KINKED. THE STENT DID NOT DEPLOY AT ALL. A NEW, SAME SIZE, ABSOLUTE PRO STENT WAS ADVANCED AND THE STENT PARTIALLY DEPLOYED FROM THE SHEATH. THE STENT WAS ABLE TO BE REMOVED, ALTHOUGH IT WAS DAMAGED. A NEW ABSOLUTE PRO STENT WAS ABLE TO BE SUCCESSFULLY DEPLOYED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE FIRST 6.0X100 ABSOLUTE PRO STENT WAS PARTIALLY EXPOSED FOR A LENGTH OF 1MM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10083578 ↗