Absolute Pro 1012536-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648176142), received between Mar 8, 2017 and May 13, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Stretched; Device Damaged by Another Device; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED RIGHT EXTERNAL ILIAC ARTERY LESION WITH 50% STENOSIS. THE 8X40 MM ABSOLUTE PRO SELF-EXPANDING STENT WAS DEPLOYED WITHOUT ISSUE. DURING POST DILATION, A BALLOON DILATATION CATHETER WAS ADVANCED; HOWEVER, MET RESISTANCE WITH THE IMPLANTED STENT AND BECAME CAUGHT ON THE DISTAL END OF THE STENT, CAUSING THE STENT TO BE STRETCHED ON THAT END. AN ADDITIONAL 8X40 MM ABSOLUTE PRO WAS IMPLANTED TO COVER THE STRETCHED PORTION OF THE STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162891 ↗
• MalfunctionNov 25, 2025Premature Activation; Difficult to Remove; Difficult to Advance; Premature Activation; Difficult to Remove; Difficult to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS REPORTED THAT THE DEVICE BECAME STUCK DURING ADVANCEMENT JUST OUTSIDE THE SHEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649357 ↗
• MalfunctionNov 3, 2025Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT EXTERNAL ILIAC ARTERY WITH MODERATE CALCIFICATION AND NO TORTUOSITY. THE 8X40 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND DEPLOYMENT WAS STARTED HOWEVER THE PHYSICIAN HAD A DIFFICULT TIME ROLLING THE THUMBWHEEL DUE TO SIGNIFICANT RESISTANCE. THE STENT WAS ABLE TO BE DEPLOYED DESPITE THE SIGNIFICANT RESISTANCE IN THE THUMBWHEEL. THERE WERE NO ADVERSE PATIENT EFFECTS, NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453068 ↗
• MalfunctionApr 22, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT ILIAC ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. APPROACH WAS THROUGH THE RADIAL ARTERY USING A 6F (FRENCH) SHEATH. THE 8.0X40MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) HAD NO RESISTANCE DURING ADVANCEMENT AND WAS ATTEMPTED TO BE POSITIONED IN THE TARGET LESION WHEN THE 6F SHEATH TIP APPEARED TO BE CAUSING ISSUES WITH ADVANCEMENT. THE PHYSICIAN NOTED THAT SHE WAS HAVING ISSUES WITH THIS SHEATH THROUGHOUT THE CASE. IT WAS THEN DECIDED TO RETRACT THE ABSOLUTE PRO WITHOUT FORCE AND THE STENT REMAINED INTACT BUT THE OUTER COVERING OF THE SESS SHEATH STILL CONNECTED TO THE DEVICE; HOWEVER, DETACHED FROM THE BASE. THE DEVICES WERE REMOVED TOGETHER AS A SINGLE UNIT AS THERE WAS RESISTANCE DURING REMOVAL WITH THE 6F SHEATH. THE STENT WAS DEEMED UNUSABLE AT THAT POINT AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT INTACT. ANOTHER STENT THROUGH THE NEW RIGHT GROIN ACCESS AND A NON-ABBOTT CLOSURE DEVICE COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND ALTHOUGH THERE WAS A MODERATE DELAY IN THE PROCEDURE; THERE WAS NO PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19160205 ↗
• InjuryDec 23, 2021Off-Label Use; Material Separation; Off-Label Use; Material Separation

  SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS PROVIDED. THE PROCEDURE WAS PERFORMED TO TREAT AN ARTERIOVENOUS (AV) FISTULA IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS FIRST TREATED WITH A NON-ABBOTT COVERED STENT AND THEN THE ABSOLUTE PRO VASCULAR STENT WAS IMPLANTED. THE ABSOLUTE PRO VASCULAR WAS THEN POST-DILATED WITH A 7.0 X 60 MM NON-ABBOTT DILATATION CATHETER BALLOON. THE ABSOLUTE PRO VASCULAR STENT THEN SEPARATED INTO PIECES, WITH AN ADDITIONAL NON-ABBOTT COVERED STENT IMPLANTED TO CRUSH THE STENT FRAGMENTS TO THE VESSEL WALL. THE PATIENT IS DOING WELL.

  Patient problems: Device Embedded In Tissue or Plaque; Embolism/Embolus; Foreign Body In Patient

  MAUDE report 13082074 ↗
• MalfunctionDec 23, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE STENT IMPLANT OF AN 8X40MM ABSOLUTE PRO VASCULAR WAS ALREADY PARTIALLY DEPLOYED (EXPOSED BUT NOT FLOWERED). ANOTHER STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. 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 13079231 ↗
• MalfunctionApr 1, 2021Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN ARTERIOVENOUS (AV) FISTULA. THE ABSOLUTE PRO WAS IMPLANTED IN THE FISTULA, WITHOUT ISSUE, AND POST DILATED WITH AN 8X40MM ARMADA 35 BALLOON DILATATION CATHETER (BDC). AFTER POST DILATATION, THE STENT WAS NOTED TO BE FRACTURED IN THE MID AREA. THE VESSEL WAS OPENED UP AFTER POST DILATATION WITH THE BALLOON; THEREFORE, NO ADDITIONAL TREATMENT WAS NEEDED AND THE FRACTURED STENT WAS LEFT AS IS. THE PROCEDURE WAS COMPLETE AT THIS TIME. 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 11606028 ↗
• MalfunctionFeb 13, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT WHILE UNPACKING THE 8.0X40 MM ABSOLUTE PRO VASCULAR STENT DELIVERY SYSTEM, IT WAS NOTED THAT THE DISTAL END OF THE STENT WAS OPENED AND FLOWERED. THERE WAS NO REPORTED DEVICE USE AND NO REPORTED PATIENT INVOLVEMENT. A NEW, SAME SIZE ABSOLUTE PRO VASCULAR STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE STENT WAS ONLY PARTIALLY EXPOSED, BUT NOT FLOWERED AS INITIALLY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9708026 ↗
• InjuryFeb 12, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, A PERCUTANEOUS TRANSLUMINAL INTERVENTION WAS PERFORMED ON THE RIGHT EXTERNAL ILIAC ARTERY. AN ABSOLUTE PRO STENT DELIVERY SYSTEM ADVANCED TO THE LESION WITHOUT ISSUE. DURING STENT DEPLOYMENT, WITHOUT UNUSUAL RESISTANCE OR ISSUES NOTED, THE STENT JUMPED FARTHER THAN EXPECTED TO AN UNINTENDED SPOT AND PARTIALLY AT THE PLANNED LESION SITE. ANOTHER STENT WAS IMPLANTED AS TREATMENT TO COVER THE PROXIMAL LESION (THIS WAS NOT PREVIOUSLY PLANNED). THERE WAS NO ADVERSE PATIENT SEQUELA 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 9701138 ↗
• InjuryJul 25, 2019Material Separation; Patient-Device Incompatibility; Material Separation; Patient-Device Incompatibility

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED ON (B)(6) 2019 TO TREAT A LESION IN THE 60% STENOSED PULMONARY VEIN. THE 8.0X40MM ABSOLUTE PRO STENT WAS DEPLOYED IN THE LESION HOWEVER THE STENT DID NOT APPEAR TO BE FULLY APPOSED TO THE VESSEL WALL. ON (B)(6) 2019, AN ATTEMPT WAS MADE TO REMOVE THE DEPLOYED STENT WITH A SNARE DEVICE HOWEVER THE STENT SEPARATED. ALL PARTS OF THE STENT WERE RETRIEVED AND REMOVED FROM THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826366 ↗
• MalfunctionNov 6, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INCOMING INSPECTION OF AN 8.0X40MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) A SMALL PIECE OF WHITE FOREIGN MATERIAL WAS FOUND INSIDE THE SEALED STERILE POUCH. THE INCIDENT OCCURRED DURING AN INSPECTION OF A CONSIGNMENT RETURN AT THE DISTRIBUTION CENTER. THE SESS WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8044459 ↗
• MalfunctionOct 12, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INCOMING INSPECTION OF AN 8X40MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) A SMALL PIECE OF WHITE FOREIGN PARTICLE WAS INSIDE THE STERILE POUCH. THE INNER POUCH WAS INTACT AND THE STERILITY OF THE DEVICE WAS NOT COMPROMISED. THE INCIDENT OCCURRED DURING AN INSPECTION OF A CONSIGNMENT RETURN AT THE DISTRIBUTION CENTER. THE SESS WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7962923 ↗
• MalfunctionMar 8, 2017Premature Activation

  IT WAS REPORTED THAT WHEN THE ABSOLUTE PRO VASCULAR 8.0/40MM/135CM SELF-EXPANDING STENT SYSTEM WAS REMOVED FROM THE HOOP, THE STENT WAS EXPOSED. THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER ABSOLUTE PRO WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6387911 ↗