Absolute Pro 1012537-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648176258), received between Apr 19, 2019 and Nov 10, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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. 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.

• MalfunctionNov 10, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED EXTERNAL ILIAC ARTERY. WHEN DEPLOYING A 9.0 X 100 MM ABSOLUTE PRO SELF-EXPANDING STENT, IT WAS ONLY ABLE TO PARTIALLY DEPLOY. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512712 ↗
• MalfunctionAug 20, 2022Stretched; Device Damaged by Another Device; Stretched; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 98% STENOSED LESION IN THE LEFT EXTERNAL ILIAC ARTERY. A 9X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS IMPLANTED WITHOUT ISSUE. DURING POST-DILATATION, WHILE ADVANCING WITH A 9X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), THE PHYSICIAN PUSHED THE EDGE OF THE TIP OF THE ARMADA BDC AGAINST THE IMPLANTED ABSOLUTE PRO STENT CAUSING RESISTANCE BETWEEN THE DEVICES, AND THE ABSOLUTE PRO SESS BECAME STRETCHED. THE BDC WAS REMOVED AND REPLACED WITH A VIATRAC 14 PLUS PERIPHERAL BALLOON DILATATION CATHETER TO COMPLETE POST-DILATATION, WHEN THE BALLOON WAS INFLATED TO 24 ATMOSPHERES (ATM) AND RUPTURED ON THE FIRST INFLATION. THE VIATRAC BDC WAS REMOVED AND THE ARMADA BDC WAS RE-INSERTED TO SUCCESSFULLY COMPLETE THE POST-DILATATION. THE STRETCHED ABSOLUTE SESS REMAINS IMPLANTED. THERE WERE 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 15263210 ↗
• MalfunctionApr 29, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE SYRINGE BECAME STUCK ON THE FLUSH PORT OF A 9X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS), AND WHEN THEY TRYTO TWIST THE SYRINGE OFF FROM THE FLUSH PORT, THE CATHETER SEPARATED FROM THE DEVICE HANDLE. ANOTHER ABSOLUTE PRO SESS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14255909 ↗
• InjuryDec 29, 2021Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT EXTERNAL ILIAC ARTERY. THE 9.0X100MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION AND THE STENT WAS DEPLOYED WITH NO ISSUES. POST DEPLOYMENT, A MID STENT FRACTURE WAS OBSERVED. A 7.0X39 OMNILINK STENT WAS SUCCESSFULLY DEPLOYED TO CORRECT THE STENT FRACTURE AND REMAINS IN ONE PIECE. THERE WAS GOOD FLOW. THERE WAS NO ADVERSE PATIENT SEQUELA 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 13112277 ↗
• InjuryApr 19, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE 9.0X100 MM ABSOLUTE PRO VASCULAR STENT WAS DEPLOYED IN THE PRE-DILATED, RIGHT EXTERNAL ILIAC VIA THE RADIAL ARTERY ACCESS SITE. AFTER THE STENT WAS DEPLOYED, THE DISTAL END OF THE STENT WAS NARROWED. THE PHYSICIAN FELT THIS WAS A DEVICE ISSUE AND NOT RELATED TO THE LESION ITSELF. AN 8.0X80 MM ARMADA 35 BALLOON DILATATION CATHETER WAS ADVANCED THROUGH THE STENT LUMEN TO POST DILATE THE ABSOLUTE PRO STENT AND FULLY EXPAND THE DISTAL END OF THE STENT. A HERCULINK ELITE STENT WAS ALSO DEPLOYED ON THE DISTAL END OF THE ABSOLUTE PRO STENT TO KEEP IT OPEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532157 ↗