Absolute Pro 1012529-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648175626), received between Aug 11, 2017 and Oct 24, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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.

• MalfunctionOct 24, 2023Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. THE 7.0X40MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ATTEMPTED TO BE RELEASED; HOWEVER, THE THUMBWHEEL WOULDN'T MOVE. THE STENT COMPLETELY FAILED TO DEPLOY. ANOTHER ABSOLUTE PRO V WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE STENT WAS PARTIALLY DEPLOYED AND FLOWERED; HOWEVER, THE ACCOUNT STATED THAT THEY WERE NOT AWARE OF THE EXPOSURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999413 ↗
• MalfunctionNov 6, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INCOMING INSPECTION OF A 7.0X40MM 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 8044506 ↗
• MalfunctionSep 13, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS NOTICED ON THE STERILIZATION PACKAGING OF AN 7.0X40 MM ABSOLUTE PRO VASCULAR STENT-EXPANDING SYSTEM (SESS) DURING INCOMING INSPECTION AT (B)(4). THE STERILIZATION PACKAGING WAS NOT OPENED, THERE WAS NO DAMAGE TO THE INNER POUCH, AND THE STERILITY OF THE DEVICE WAS NOT COMPROMISED. THE SESS WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE RETURN ANALYSIS INDICATED THAT PER CHEM ANALYSIS, COLORED FOREIGN PARTICLE INSIDE THE STERILE POUCH NEAR THE MANUFACTURING SEAL COULD NOT BE IDENTIFIED BUT HAD SOME RESEMBLANCE TO TYPES OF THERMOPLASTICS SUCH AS PEEK AND POLYSULFONE.

  Patient problems: No Patient Involvement

  MAUDE report 7873589 ↗
• InjuryAug 11, 2017Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ILIAC ARTERY. A 7.0 X 40 MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT WAS IMPLANTED ON (B)(6) 2015, AND THE PATIENT WAS SENT HOME THAT DAY. HOWEVER, 30 MINUTES AFTER THE PROCEDURE WAS DONE, THE PATIENT FELT A POP AT THE INCISION SITE. THREE DAYS LATER THE PATIENT BEGAN LOSING A SIGNIFICANT AMOUNT OF BLOOD BECAUSE THE ACCESS SITE WAS CUT DURING THE PROCEDURE. THE PATIENT PASSED OUT AND WAS RE-HOSPITALIZED ON (B)(6) 2015 TO TREAT THE BLOOD LOSS. YESTERDAY, ON (B)(6) 2017, THE PATIENT WENT TO SEE HER PODIATRIST BECAUSE SHE HAS BEEN EXPERIENCING A SHARP PAIN IN HER LEG SINCE (B)(6) 2017, WHICH TURNED A DARK PURPLE COLOR. HER FEET BECAME COLDER, AND HER PODIATRIST COULD NOT GET A PULSE ON EITHER FOOT. THE PODIATRIST STATED THAT THE STENT IMPLANT MAY HAVE MOVED OR MIGRATED FROM ITS LOCATION. THE PATIENT WILL SEE HER PHYSICIAN TO CONFIRM HER SYMPTOMS. THE PATIENT HAS NOT BEEN TAKING ANY MEDICATION SINCE THEIR PROCEDURE. THERE WAS NO ADDITIONAL ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion; Pain

  MAUDE report 6790270 ↗