Absolute Pro 1012532-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648175848), received between Jun 22, 2017 and Oct 15, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Improper 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 LEFT EXTERNAL ILIAC ARTERY VIA RIGHT COMMON FEMORAL ACCESS. THERE WAS MODERATE TORTUOSITY AND A STEEP AORTIC BIFURCATION. THE LESION WAS PRE-DILATED WITH A 6X40 ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER. THE 10X40 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND UPON DEPLOYMENT THE THUMBWHEEL WAS DIFFICULT TO ROLL. THE STENT WAS IMPLANTED AFTER BOTH HANDS WERE FORCEFULLY USED TO DEPLOY THE STENT. 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 23292094 ↗
• MalfunctionNov 4, 2020Device Dislodged or Dislocated; Mechanical Jam; Activation Failure; Device Dislodged or Dislocated; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT COMMON ILIAC ARTERY WITH NO CALCIFICATION OR TORTUOSITY NOTED. DURING THE PROCEDURE, THE 10.0X40 MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WOULD NOT UNLOCK TO BEGIN DEPLOYMENT OF THE STENT. DURING REMOVAL OF THE SESS, WITH THE UNDEPLOYED STENT, IT WAS OBSERVED THAT THE STENT HAD DEPLOYED ON THE GUIDE WIRE INSIDE THE 6FR SHEATH. THE SHEATH, SESS AND STENT WERE ALL REMOVED AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED 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 10786984 ↗
• MalfunctionJul 19, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO, ECCENTRIC LESION IN THE MILDLY TORTUOUS, MILDLY CALCIFIED COMMON ILIAC ARTERY. AFTER A NON-ABBOTT BALLOON WAS INFLATED ONCE AT EIGHT ATMOSPHERES FOR 60 SECONDS, A 10X40MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND THE STENT WAS DEPLOYED. THE PROXIMAL MARKER OF THE ABSOLUTE PRO SESS BECAME STUCK WITH A NON-ABBOTT INTRODUCER SHEATH DURING REMOVAL. THE DEVICE WAS REMOVED TOGETHER WITH THE SHEATH AS A SINGLE UNIT. THE SESS WAS UNABLE TO BE REMOVED FROM THE SHEATH DESPITE INTENTIONAL MANIPULATION OUTSIDE THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809485 ↗
• MalfunctionJun 22, 2017Inaccurate Delivery

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE HEAVILY TORTUOUS, DE NOVO LEFT AND RIGHT COMMON ILIAC ARTERY (CIA) THE 10X40X135MM ABSOLUTE STENT WAS ADVANCED FROM THE LEFT BRACHIAL TO THE LESION IN LEFT CIA AND A 10X40X80MM ABSOLUTE PRO STENT WAS ADVANCED FROM THE RIGHT SFA (IPSILATERAL RETROGRADE APPROACH) TO THE LESION IN RIGHT CIA. IT WAS NOTED THAT DURING DEPLOYMENT AT THE SAME TIME BOTH STENTS JUMPED NOT FULLY IN THE TARGET LESION. ONE EACH 8 X 40 MM ADDITIONAL STENT WAS USED TO FULLY COVER BOTH TARGET LESION LOCATIONS WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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 6661656 ↗