Absolute Pro 1012534-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648175978), received between Aug 4, 2017 and Aug 28, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2020Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT SUPERIOR FEMORAL ARTERY. ONE STENT WAS SUCCESSFULLY PLACED. THE 6.0X30MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITH RESISTANCE NOTED. ONCE THE SESS WAS ADVANCED TO THE PREVIOUSLY PLACED STENT, IT WAS NOTED THE STENT WAS STICKING OUT FROM THE SHEATH APPROXIMATELY 1MM AND WOULD NOT ADVANCE THROUGH THE STENT. THE SESS WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE COMPLETED WITH ANOTHER DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10465485 ↗
• MalfunctionAug 20, 2019Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED LEFT EXTERNAL CAROTID ARTERY. A 60 X 30 MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM WAS USED AND MET INITIAL RESISTANCE WITH THE SHEATH DURING ADVANCEMENT. HOWEVER, BEFORE REACHING THE TARGET, IT WAS OBSERVED UNDER FLOUROSCOPY THAT THERE WAS NO STENT ON THE BALLOON. THE DEVICE WAS PULLED BACK, AND THE STENT HAD PREMATURELY DEPLOYED IN THE SHEATH. A PART OF THE STENT WAS STICKING OUT OF THE SHEATH. THE DEVICE WAS THEN REMOVED AS A SINGLE UNIT WITH SHEATH WITHOUT ANY ISSUES. THE DEVICE DID NOT SEPARATE INTO TWO SEPARATE PIECES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8911627 ↗
• InjuryAug 22, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION IN THE INTERNAL CAROTID ARTERY AND COMMON CAROTID ARTERY. AN EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM WAS ADVANCED AND DEPLOYED. A 4X30 MM VIATRAC DILATATION CATHETER WAS USED FOR PRE-DILATATION. A XACT 8TX40X136 CAROTID STENT SYSTEM WAS ADVANCED AND DEPLOYED WITHOUT ANY ISSUE IN THE INTERNAL CAROTID ARTERY. A 6-8 X 40 MM ACCULINK STENT SYSTEM WAS ADVANCED AND DEPLOYED SUCCESSFULLY IN THE COMMON CAROTID ARTERY; A 6X30X135 VIATRAC PLUS DILATATION CATHETER WAS USED FOR POST DILATATION. UPON COMPLETION OF THE PROCEDURE, AFTER THE EMBOSHIELD NAV 6 WAS REMOVED; THE PATIENT EXPERIENCED FACIAL DROOPING, RIGHT SIDE MOTOR FUNCTION LOSS, AND INCOHERENT SPEECH. THE PATIENT HAD A STROKE. MEDICATION WAS USED FOR TREATMENT AND THE SYMPTOMS RESOLVED. IT IS THE PHYSICIANS OPINION THAT THE STROKE AND SYMPTOMS ARE NOT RELATED TO THE XACT STENT BUT ARE RELATED TO RADIATION THE PATIENT PREVIOUSLY RECEIVED FOR A NECK TUMOR. THE PATIENT REMAINS HOSPITALIZED, BUT IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Neurological Deficit/Dysfunction; Stroke/CVA; Visual Disturbances; Weakness

  MAUDE report 6811949 ↗
• MalfunctionAug 4, 2017Defective Device

  IT WAS REPORTED THAT A 6X30MM ABSOLUTE PRO STENT DELIVERY SYSTEM (SDS)ADVANCED TO THE EXTERNAL ILIAC LESION WITHOUT ISSUE. THE STENT WAS DEPLOYED WITHOUT ISSUE AND WAS FULLY APPOSED TO THE VESSEL WALL. IT WAS THEN NOTED THAT THE STENT APPEARED LONGER THAN 30MM; THE STENT APPEARED OVER 35MM IN LENGTH. THERE WAS NO ELONGATION OR STRETCHING OF THE STENT; HOWEVER, THE STENT ITSELF APPEARED LONGER. THE STENT REMAINED AT THE LESION SITE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6767830 ↗