Absolute Pro 1012534-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648175961), received between May 16, 2018 and Feb 11, 2026 — classified as 1 injury, 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Malposition of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY. A CSI DEVICE AND UNSPECIFIED BALLOON WERE USED TO PREPARE THE LESION. ONCE AT THE LESION, THE 6.0X20MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED OVER A 0.014 NON-ABBOTT WIRE; HOWEVER, DURING DEPLOYMENT, THE STENT DID NOT FLOWER INITIALLY, THEN JUMPED AND FULLY DEPLOYED AT AN UNINTENDED LOCATION. A NEW 6.0X20MM ABSOLUTE PRO SES WAS DEPLOYED AT THE INTENDED SITE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24315352 ↗
• MalfunctionDec 24, 2020Break; Difficult to Insert; Material Twisted/Bent; Material Split, Cut or Torn; Break; Difficult to Insert; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE ABSOLUTE PRO STENT DELIVERY SYSTEM WAS UNABLE TO BE INSERTED/BACK LOADED UNTO THE UNSPECIFIED GUIDE WIRE. A BENDING WAS THEN OBSERVED ON THE ABSOLUTE PRO CATHETER. THE EXACT LOCATION OF THE BEND WAS NOT SPECIFIED BY THE ACCOUNT. THE DEVICE WAS SET ASIDE AND NOT USED. THERE WAS NO ADVERSE PATIENT EFFECT OR OTHER DEVICE ISSUES REPORTED. ANOTHER DEVICE WAS SUCCESSFULLY USED IN REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE. SUBSEQUENTLY THE DEVICE WAS RECEIVED AT ABBOTT VASCULAR AND PRELIMINARY ANALYSIS REVEALED MULTIPLE TEARS ON THE JACKET AT THE LOCATION OF THE KINK. THE INNER BRAIDING MATERIAL WAS SEPARATED (NOT IN TWO SEPARATE PIECES) WITHIN THE JACKET AT THE LOCATION OF THE KINK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11072428 ↗
• MalfunctionFeb 18, 2020Deformation Due to Compressive Stress; Mechanical Jam; Activation Failure; Deformation Due to Compressive Stress; Mechanical Jam; Activation Failure

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED SUBSEQUENT TO FILING THE FINAL MDR: THE CASE WAS A FEMORAL TO FEMORAL CROSSOVER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9722588 ↗
• MalfunctionMay 16, 2018Premature Activation

  IT WAS REPORTED THAT THE 6.0/20 MM ABSOLUTE PRO STENT WAS OBSERVED TO BE PARTIALLY DEPLOYED/FLOWERING WHILE STILL IN THE PACKAGING. THE DEVICE WAS NOT USED ON THE PATIENT. A NEW ABSOLUTE PRO STENT DELIVERY SYSTEM WAS USED SUCCESSFULLY FOR THE CASE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS REVEALED THE STENT IMPLANT WAS EXPOSED, NOT FLOWERING AS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7519750 ↗