Absolute Pro 1012530-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648175732), received between Apr 2, 2018 and Dec 15, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2024Premature Activation; Activation Failure; Premature Activation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT EXTERNAL ILIAC ARTERY WITH CALCIFICATION AND 85% STENOSIS. THE 8X100 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND DEPLOYMENT WAS STARTED. THE STENT WAS ABOUT HALFWAY DEPLOYED WHEN THE DEPLOYMENT STOPPED DESPITE THE WHEEL MOVING FREELY. IT WAS DECIDED TO REMOVE THE STENT AND DELIVERY SYSTEM; HOWEVER, UPON REMOVAL, THE REST OF THE STENT DEPLOYED INSIDE THE TARGET LESION. POST DILATATION WAS PERFORMED PER STANDARD PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 20935876 ↗
• MalfunctionDec 23, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, 85% STENOSED LESION IN THE LEFT EXTERNAL ILIAC ARTERY. PRE-DILATATION WAS COMPLETED WITH A NON-ABBOTT SHOCK WAVE BALLOON, AND AN 8X100MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. ONCE AT THE LESION, THE THUMBWHEEL WAS ATTEMPTED TO BE TURNED BUT WOULD NOT MOVE. TROUBLE SHOOTING WAS PERFORMED BY LOCKING AND UNLOCKING THE DEVICE, AFTER WHICH THE THUMBWHEEL WORKED WITHOUT ISSUE AND THE STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13081919 ↗
• MalfunctionNov 29, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THERE WAS A WHITE FOREIGN MATERIAL IN THE STERILE PACKAGING OF A 8.0 X 100 MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS). THERE WAS NO REPORTED DAMAGE TO THE INNER POUCH OR THE SESS. 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. RETURN DEVICE ANALYSIS IDENTIFIED THAT THE FOREIGN MATERIAL NOTED ON THE INSIDE OF THE STERILE POUCH OF THE SESS WAS A MANUFACTURING COMPONENT.

  Patient problems: No Patient Involvement

  MAUDE report 8116587 ↗
• MalfunctionNov 12, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INCOMING INSPECTION OF AN 7X60MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) A SMALL PIECE OF WHITE FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE POUCH. A SMALL PIECE OF BLACK FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE POUCH OF AN 8X40MM ABSOLUTE PRO VASCULAR SESS AND A SMALL PIECE OF PURPLE FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE POUCH OF AN 8X100MM ABSOLUTE PRO VASCULAR SESS. THE INNER POUCHES WERE INTACT AND THE STERILITY OF THE DEVICES 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 8062214 ↗
• InjurySep 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE EXTERNAL ILIAC ARTERY WITH 100% STENOSIS. ON (B)(6) 2018, THE PATIENT PRESENTED WITH INTERMITTENT CLAUDICATION. AN 8.0 X 100 MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM WAS SUCCESSFULLY DEPLOYED. POST-IMPLANTATION, THE ANKLE BRACHIAL INDEX (ABI) BECAME WORSE. BLOOD PRESSURE OF THE ANKLE AND BRACHIAL WERE MEASURED AND THE COMPUTED TOMOGRAPHY (CT) REVEALED ACUTE IN-STENT OCCLUSION [THROMBOSIS]. ON (B)(6) 2018, THE PATIENT RECEIVED A FOLLOW-UP EXAM AND THE PATIENT STILL HAD CLAUDICATION. ON (B)(6) 2018, A CT WAS PERFORMED ON THE PATIENT DUE TO SYMPTOMS FROM (B)(6) 2018 FOLLOW-UP. ON (B)(6) 2018, TREATMENT WAS PERFORMED TO TREAT THE IN-STENT THROMBOSIS. THE THROMBOSIS IN THE STENT WAS ASPIRATED AND A NON-ABBOTT STENT WAS IMPLANTED. THE PATIENT WAS PRESCRIBED DOSES OF DUAL ANTIPLATELET DRUG THERAPY (DAPT), POST-PROCEDURE. REPORTEDLY, THE PHYSICIAN SUSPECTED THE POSSIBILITY OF METAL ALLERGY DUE TO THE ACUTE OCCLUSION [THROMBOSIS] WHICH WAS PROVEN BY DRUG LYMPHOCYTE STIMULATION ALLERGY TEST GIVEN TO THE PATIENT. THE PATIENT WAS GIVEN DIRECT ORAL ANTICOAGULANTS TO TREAT THE ALLERGY. ON (B)(6) 2018, THE ABI

  Patient problems: Claudication; Hypersensitivity/Allergic reaction; Thrombosis

  MAUDE report 7887135 ↗
• InjurySep 14, 2018Difficult to Remove; Material Separation; Difficult to Advance; Mechanical Jam; Activation Failure; Difficult to Remove; Material Separation; Difficult to Advance; Mechanical Jam; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT COMMON ILIAC. THE 8.0X100MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITH RESISTANCE NOTED DUE TO THE ANATOMY. DURING ATTEMPTED DEPLOYMENT, THE THUMBSLIDE FAILED TO COMPLETELY DEPLOY THE STENT. RESISTANCE WAS MET DURING RETRACTION AND A PIECE OF THE STENT SEPARATED IN THE PATIENT ANATOMY. A COVERED STENT WAS USED TO EMBED THE SEPARATED PORTION OF THE ABSOLUTE PRO STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7878242 ↗
• MalfunctionJul 26, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INCOMING INSPECTION AT CENTURY MEDICAL DISTRIBUTION CENTER, A PURPLE FOREIGN MATERIAL WAS NOTED IN THE STERILIZATION PACKAGING OF A 8.0 X 100 MM ABSOLUTE PRO VASCULAR SELF-EXPANDING SYSTEM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. CHEMICAL ANALYSIS REPORT CONCLUDED THE LOOSE UNKNOWN PURPLE MATERIAL IN THE HEADER BAG WAS POLYCARBONATE AND MAY HAVE COME FROM THE HANDLE PORT.

  Patient problems: No Patient Involvement

  MAUDE report 7724290 ↗
• MalfunctionApr 2, 2018Device Expiration Issue; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AN EXPIRED ABSOLUTE PRO STENT WAS IMPLANTED IN THE LEFT ILIAC ARTERY. 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 7390627 ↗