Absolute Pro 1012537-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648176234), received between Oct 15, 2018 and Feb 13, 2025 — classified as 1 injury, 4 malfunctions.

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

• MalfunctionFeb 13, 2025Material Separation; Material Deformation; Mechanical Jam; Activation Failure; Material Separation; Material Deformation; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT ILIAC ARTERY. A 9X60MM ABSOLUTE PRO SELF-EXPANDING STENT (SES) WAS ADVANCED THROUGH A 6F SHEATH AND OVER A .035X300CM SUPRA CORE GUIDEWIRE TO THE TARGET LESION, WITH NO NOTED RESISTANCE; HOWEVER; DURING DEPLOYMENT THE THUMBWHEEL WAS NOTED TO JAM AND THE STENT COULD ONLY BE PARTIALLY DEPLOYED. THE SES WAS REMOVED THROUGH THE SHEATH AND A NEW NON-ABBOTT STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. SUBSEQUENT TO THE INITIALLY REPORTED EVENT, THE DEVICE WAS RECEIVED AND THE RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT SHEATH WAS SEPARATED 2 CM FROM THE DISTAL END OF THE TIP, AND THE DISTAL END OF THE STENT IMPLANT WAS BENT, STRETCHED, AND HAD BROKEN STRUTS. FOLLOW-UP WITH THE ACCOUNT CONFIRMED THAT ALL NOTED DAMAGES FOUND IN THE DEVICE ANALYSIS OCCURRED DURING THE PROCEDURE WHEN THE PORTION OF THE STENT THAT WAS DEPLOYED WAS RE-SHEATHED AND PULLED THROUGH THE 6F SHEATH FOR REMOVAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375992 ↗
• MalfunctionSep 16, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNKNOWN VESSEL. REPORTEDLY A 9.0MM X 60MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT (SES) WAS PREPARED; HOWEVER, COULD NOT BE ADVANCED OVER THE GUIDEWIRE. THE SES WAS REPLACED WITH ANOTHER ABSOLUTE PRO AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE JACKET WAS SEPARATED BUT HELD TOGETHER BY THE JACKET MATERIAL. THE ACCOUNT WAS NOT AWARE OF THE DAMAGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225455 ↗
• InjuryMay 4, 2020Material Separation; Difficult or Delayed Activation; Physical Resistance/Sticking; Material Separation; Difficult or Delayed Activation; Physical Resistance/Sticking

  SUBSEQUENT TO FILING THE FINAL MDR, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE CASE WAS A CONTRALATERAL APPROACH. THE SHEATH WAS IN THE LEFT COMMON FEMORAL ARTERY AND THE PHYSICIAN WAS ATTEMPTING TO STENT THE RIGHT ILIAC. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10021068 ↗
• MalfunctionDec 13, 2018Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS INTERVENTION TREATING THE EXTERNAL ILIAC. BEFORE ENTERING INTO THE PATIENT'S ANATOMY, THE ABSOLUTE PRO STENT DELIVERY SYSTEM (SDS) ADVANCED OVER A GUIDE WIRE. REPORTEDLY, FOLLOWING INSERTION, RESISTANCE WAS FELT WHILE ADVANCING THE SDS OVER THE GUIDE WIRE. ONCE AT THE SHEATH AND BEFORE ENTERING THE ANATOMY, THE STENT HAD PREMATURELY DEPLOYED AS STENT FLOWERING WAS OBSERVED. THE DEVICE WAS EASILY REMOVED AND A NON-ABBOTT DEVICE WAS USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160508 ↗
• MalfunctionOct 15, 2018Material Separation; Difficult or Delayed Activation; Material Separation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE 9.0X60 MM ABSOLUTE PRO STENT WAS ADVANCED TO THE HEAVILY CALCIFIED, RIGHT EXTERNAL ILIAC ARTERY, BUT ONLY PARTIALLY DEPLOYED. THE CATHETERIZATION LAB STAFF DOCUMENTED A FRACTURE ON THE DEVICE, BUT THE PHYSICIAN'S NOTES DID NOT MENTION THIS DEVICE. THE VESSEL WAS TREATED WITH BALLOON DILATATION USING AN 8.0X40 MM ARMADA. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7966031 ↗