Absolute Pro 1012536-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648176135), received between Oct 24, 2017 and Oct 2, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2020Entrapment of Device; Malposition of Device; Migration; Entrapment of Device; Malposition of Device; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT AV FISTULA. AN ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION; HOWEVER, UPON TURNING THE WHEEL TO DEPLOY THE STENT, THE STENT FLOWERED AND JUMPED OUT. AN ATTEMPT WAS MADE TO SNARE THE STENT, BUT THE STENT MIGRATED INTO THE LEFT PULMONARY AND BECAME LODGED THERE. ANOTHER SAME SIZED ABSOLUTE STENT WAS USED TO SUCCESSFULLY TREAT THE LESION. THE PATIENT WILL BE TRANSFERRED TO SURGERY TO REMOVE THE FOREIGN BODY IN THE LEFT PULMONARY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10621532 ↗
• MalfunctionApr 10, 2020Defective Device; Device Markings/Labelling Problem; Defective Device; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT EXTERNAL ILIAC ARTERY. AN 8 X 30 X 135 CM ABSOLUTE PRO VASCULAR STENT WAS DEPLOYED IN THE LEFT EXTERNAL ILIAC. THERE WERE NO COMPLICATIONS WITH DEPLOYMENT. THE LESION WAS POST DILATED WITH AN 8 X 40 BALLOON, AND THE BALLOON WAS THE SAME LENGTH AS THE STENT. THE BALLOON WAS MEASURED AGAINST OTHER 40 MM BALLOONS THAT HAD BEEN UTILIZED TO PREP THE LESION, AND IT WAS THE CORRECT LENGTH. BASED ON THIS, IT WAS FELT THAT THE STENT WAS LONGER THAN IT¿S LABELED LENGTH. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9950350 ↗
• MalfunctionOct 24, 2017Premature Activation; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT EXTERNAL ILIAC ARTERY THAT DID NOT HAVE ANY TORTUOSITY OR CALCIFICATION. THE ACCESS SITE WAS THE RIGHT FEMORAL ARTERY. AN 8.0 X 30 MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM CROSSED THE LESION AND THEN WAS REMOVED IN ORDER TO PRE-DILATE THE LESION WITH AN UNSPECIFIED BALLOON CATHETER. THE DEVICE DID NOT MEET ANY RESISTANCE WHEN ADVANCING TOWARDS THE LESION. HOWEVER, WHEN THE DEVICE WAS BEING REMOVED OVER AN UNSPECIFIED GUIDE WIRE, THE STENT GOT CAUGHT WITH THE VALVE OF AN UNSPECIFIED INTRODUCER SHEATH OUTSIDE OF THE ANATOMY, AND DEPLOYED OVER THE GUIDE WIRE. THE DEVICE WAS NEVER UNLOCKED AND THE THUMBWHEEL WAS NOT MANIPULATED AT ALL. AN UNSPECIFIED ABSOLUTE PRO STENT WAS THEN USED TO SUCCESSFULLY 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 6974826 ↗