Absolute Pro 1012530-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648175718), received between Dec 29, 2017 and Nov 17, 2023 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2023Premature Activation; Difficult to Remove; Deformation Due to Compressive Stress; Premature Activation; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDE WIRE WAS IN THE TARGET LESION AND THE PREPARED ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS BEING ADVANCED OVER THE GUIDE WIRE, WHEN THE STENT BECAME EXPOSED [STARTED TO DEPLOY] PRIOR TO ENTERING THE INTRODUCER SHEATH. THE SESS WAS THEN ATTEMPTED TO BE REMOVED FROM THE GUIDE WIRE, HOWEVER RESISTANCE WAS MET AND THE OUTER SHEATH OF THE SESS WAS NOTED AS BUNCHED UP. THEY DECIDED TO DEPLOY THE STENT ON THE GUIDE WIRE IN ORDER TO REMOVE IT. A NEW ABSOLUTE PRO STENT WAS USED SUCCESSFULLY FOR THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18162966 ↗
• InjuryOct 30, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE ILIAC ARTERY WITH HEAVY CALCIFICATION AND NO TORTUOSITY. THE 8.0X60MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITHOUT RESISTANCE AND DEPLOYED. THE DELIVERY SYSTEM WAS REMOVED WITH A LITTLE RESISTANCE DUE TO THE ANATOMY AND THE STENT IMPLANT WAS NOTED TO BE BROKEN HAVING SEPARATED INTO TWO PIECES IN THE TARGET LESION. A SNARE DEVICE WAS USED TO REMOVE THE BROKEN STENT AND NOTHING WAS LEFT IN THE ANATOMY. AN OMNILINK ELITE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELAE 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 18031188 ↗
• MalfunctionOct 4, 2023Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 8.0X60MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS DIFFICULT TO DEPLOY BUT WAS EVENTUALLY RELEASED AND DEPLOYED IN THE TARGET LESION AFTER GREAT FORCE WAS PRESSED ON THE DEPLOYMENT HANDLE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868545 ↗
• MalfunctionJul 20, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT ILIAC ARTERY AND AN EXPIRED 8.0X60MM ABSOLUTE PRO SELF-EXPANDING STENT WAS IMPLANTED. THERE WERE NO REPORTED ADVERSE EFFECTS AND THERE WAS NO REPORTED SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200001 ↗
• MalfunctionJun 11, 2021Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  IT WAS REPORTED THAT DURING A HEAVILY CALCIFIED, MODERATELY STENOSED LEFT EXTERNAL ILIAC INTERVENTION, THE ABSOLUTE PRO WAS ADVANCED BUT FAILED TO CROSS THE LESION, SO IT WAS REMOVED; HOWEVER, WHEN REMOVED, THE TIP OF THE STENT WAS EXPOSED. ANOTHER ABSOLUTE PRO (8.0X60MM) WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 11988457 ↗
• MalfunctionJul 8, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT AND LEFT EXTERNAL ILIAC. THE BILATERAL EXTERNAL ILIAC, COMMON ILIAC, AND THE DISTAL AORTA WERE VERY CALCIFIED. SHOCKWAVE THERAPY WAS PERFORMED. THE ABSOLUTE PRO (9090461) WAS ADVANCED HOWEVER IT WAS BELIEVED THE STENT FAILED TO DEPLOY BECAUSE THE STENT MARKERS WERE NOT VISIBLE. THE DEVICE WAS REMOVED WITHOUT ISSUE. THE SAME ISSUE OCCURRED WITH TWO OTHER ABSOLUTE PRO DEVICES (9080861, 9010261); IT WAS BELIEVED THE STENTS COMPLETELY FAILED TO DEPLOY BECAUSE THE STENT MARKERS WERE NOT VISIBLE. NO OTHER ATTEMPTS WERE MADE TO STENT. THE FILMS WERE REVIEWED, THE STENTS WERE CONFIRMED TO HAVE BEEN DEPLOYED IN THE TARGET VESSELS, HOWEVER, THE MARKERS WERE NOT VISIBLE DUE TO THE PATIENT ANATOMY. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10248304 ↗
• MalfunctionJun 4, 2020Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A FISTULA GRAFT IN THE SUBCLAVIAN VEIN AND THE 8.0X60 MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT BECAME STUCK ON THE GUIDE WIRE AND COULD NOT BE DELIVERED. BOTH THE STENT AND THE GUIDE WIRE HAD TO BE REMOVED TOGETHER. A NEW STENT AND A NEW GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10120445 ↗
• MalfunctionSep 10, 2019Off-Label Use; Defective Device; Off-Label Use; Defective Device

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY SCARRED LESION IN THE CEPHALIC VEIN. PRE-DILATATION WAS PERFORMED WITH A 60 MM BALLOON. THE 8.0 X 60 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION HOWEVER THE STENT APPEARED TO BE ½ SIZE LARGER THAN IT SHOULD BE. THE STENT WAS NOT DEPLOYED AND REMOVED FROM THE PATIENT. ANOTHER ABSOLUTE PRO WAS USED TO COMPLETE THE PROCEDURE. 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 8981757 ↗
• MalfunctionSep 14, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT AN 8.0X60MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) POUCH WAS INSPECTED AT A DISTRIBUTION CENTER, AND A SMALL, TRANSPARENT PIECE OF MATERIAL WAS FOUND INSIDE OF THE STERILE POUCH. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS DETERMINED THAT THE UNKNOWN TRANSPARENT PIECE OF POLYMER-LIKE MATERIAL WAS A TYPE OF POLYETHYLENE.

  Patient problems: No Patient Involvement

  MAUDE report 7878813 ↗
• MalfunctionAug 28, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INCOMING INSPECTION AT THE DISTRIBUTION CENTER, PURPLE FOREIGN MATERIAL WAS NOTED IN THE SEALED PACKAGING OF THE ABSOLUTE PRO VASCULAR STENT SYSTEM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7823655 ↗
• InjuryDec 29, 2017Difficult or Delayed Positioning

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION WITH HEAVY CALCIFICATION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 8.0 X 60 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION. DURING STENT DEPLOYMENT, THE THUMBWHEEL BECAME STUCK AND STOPPED WORKING DUE TO THE HEAVY CALCIFICATION; HOWEVER, THE PHYSICIAN COULD MANIPULATE THE DEVICE BY PUSHING THE SHEATH FORWARD TO CONTINUE DEPLOYING THE STENT SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7154753 ↗