Absolute ProRecalls & reported problems across all models

We found 51 models of Absolute Pro by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 390 adverse event reports in the FDA's MAUDE database, received between Dec 8, 2016 and Aug 19, 2026 — classified as 1 death, 140 injuries, 249 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (99 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Absolute Pro problems

Absolute Pro models

51 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Absolute Pro 1012534-100

  STENT, ILIAC
  51 reports
• Absolute Pro 1012535-100

  STENT, ILIAC
  1 death41 reports
• Absolute Pro 1012536-100

  STENT, ILIAC
  21 reports
• Absolute Pro 1012536-80

  STENT, ILIAC
  20 reports
• Absolute Pro 1012534-40

  STENT, ILIAC
  13 reports
• Absolute Pro 1012534-60

  STENT, ILIAC
  13 reports
• Absolute Pro 1012536-40

  STENT, ILIAC
  13 reports
• Absolute Pro 1012535-40

  STENT, ILIAC
  12 reports
• Absolute Pro 1012530-40

  STENT, ILIAC
  11 reports
• Absolute Pro 1012530-60

  STENT, ILIAC
  11 reports
• Absolute Pro 1012534-80

  STENT, ILIAC
  11 reports
• Absolute Pro 1012535-60

  STENT, ILIAC
  10 reports
• Absolute Pro 1012535-80

  STENT, ILIAC
  10 reports
• Absolute Pro 1012531-60

  STENT, ILIAC
  9 reports
• Absolute Pro 1012538-100

  STENT, ILIAC
  9 reports
• Absolute Pro 1012529-60

  STENT, ILIAC
  8 reports
• Absolute Pro 1012530-100

  STENT, ILIAC
  8 reports
• Absolute Pro 1012538-40

  STENT, ILIAC
  8 reports
• Absolute Pro 1012530-80

  STENT, ILIAC
  7 reports
• Absolute Pro 1012532-100

  STENT, ILIAC
  6 reports
• Absolute Pro 1012536-60

  STENT, ILIAC
  6 reports
• Absolute Pro 1012537-40

  STENT, ILIAC
  6 reports
• Absolute Pro 1012529-100

  STENT, ILIAC
  5 reports
• Absolute Pro 1012531-40

  STENT, ILIAC
  5 reports
• Absolute Pro 1012536-20

  STENT, ILIAC
  5 reports
• Absolute Pro 1012537-60

  STENT, ILIAC
  5 reports
• Absolute Pro 1012537-100

  STENT, ILIAC
  5 reports
• Absolute Pro 1012538-60

  STENT, ILIAC
  5 reports
• Absolute Pro 1012529-40

  STENT, ILIAC
  4 reports
• Absolute Pro 1012532-40

  STENT, ILIAC
  4 reports
• Absolute Pro 1012534-20

  STENT, ILIAC
  4 reports
• Absolute Pro 1012534-30

  STENT, ILIAC
  4 reports
• Absolute Pro 1012535-20

  STENT, ILIAC
  4 reports
• Absolute Pro 1012538-80

  STENT, ILIAC
  4 reports
• Absolute Pro 1012528-40

  STENT, ILIAC
  3 reports
• Absolute Pro 1012532-80

  STENT, ILIAC
  3 reports
• Absolute Pro 1012535-30

  STENT, ILIAC
  3 reports
• Absolute Pro 1012536-30

  STENT, ILIAC
  3 reports
• Absolute Pro 1012528-60

  STENT, ILIAC
  2 reports
• Absolute Pro 1012528-100

  STENT, ILIAC
  2 reports
• Absolute Pro 1012529-30

  STENT, ILIAC
  2 reports
• Absolute Pro 1012529-80

  STENT, ILIAC
  2 reports
• Absolute Pro 1012531-80

  STENT, ILIAC
  2 reports
• Absolute Pro 1012532-60

  STENT, ILIAC
  2 reports
• Absolute Pro 1012537-80

  STENT, ILIAC
  2 reports
• Absolute Pro 1012528-30

  STENT, ILIAC
  1 report
• Absolute Pro 1012528-80

  STENT, ILIAC
  1 report
• Absolute Pro 1012530-30

  STENT, ILIAC
  1 report
• Absolute Pro 1012531-100

  STENT, ILIAC
  1 report
• Absolute Pro 1012532-30

  STENT, ILIAC
  1 report
• Absolute Pro 1012537-30

  STENT, ILIAC
  1 report

Recent Absolute Pro adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Entrapment of Device; Mechanical Jam; Activation Failure

  It was reported that the procedure was to treat a moderately calcified left superficial femoral artery lesion. An 8x100 mm Absolute Pro self-expanding stent was advanced. During deployment, resistance was noted with deployment mechanism "[thumbwheel]". The stent was deployed 20mm and became stuck. Surgery was performed to remove the stent and complete the 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 50331453 ↗
• InjuryJul 27, 2026Stretched; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Mechanical Jam

  It was reported that the procedure was to treat a de novo, moderately calcified superficial femoral artery lesion with 99% stenosis. A 6x100 mm Absolute Pro self-expanding stent was advanced along a 0.014 inch guide wire. However, during deployment, the wheel became stuck and was unable to roll. During removal, the stent became elongated and was deployed partially in healthy tissue and partially in the lesion. A new non-Abbott stent was used to maintain the vessel and complete the 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 50046150 ↗
• InjuryJul 6, 2026Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ILIAC ARTERY WITH MODERATE CALCIFICATION. THE 6X100 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS BEING ADVANCED AND THE STENT FRACTURED. A SNARE WAS USED TO RETRIEVE MOST OF THE STENT AND A COVERED STENT WAS USED TO TRAP THE REST THAT COULD NOT BE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25724903 ↗
• MalfunctionJun 23, 2026Activation Failure

  IT WAS REPORTED THAT THE 8.0X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT (SES) DID NOT DEPLOY CORRECTLY AND WAS REMOVED. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO 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 25597359 ↗
• MalfunctionJun 3, 2026Premature Activation

  IT WAS REPORTED THAT WHEN THE 8X40MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS REMOVED FROM THE PACKAGING THE STENT WAS NOTED TO BE PARTIALLY EXPOSED AND NOT FLOWERING. ANOTHER ABSOLUTE PRO STENT WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25382082 ↗
• MalfunctionJun 2, 2026Premature Activation

  IT WAS REPORTED THAT WHEN THE ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) WAS OPENED, THE STENT WAS NOTED TO BE PARTIALLY DEPLOYED AND FLOWERED. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER ABSOLUTE PRO SESS WAS USED TO COMPLETE THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE STENT WAS NOT FLOWERED AND WAS ONLY EXPOSED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363471 ↗
• InjuryMay 13, 2026Stretched; Device Damaged by Another Device; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED RIGHT EXTERNAL ILIAC ARTERY LESION WITH 50% STENOSIS. THE 8X40 MM ABSOLUTE PRO SELF-EXPANDING STENT WAS DEPLOYED WITHOUT ISSUE. DURING POST DILATION, A BALLOON DILATATION CATHETER WAS ADVANCED; HOWEVER, MET RESISTANCE WITH THE IMPLANTED STENT AND BECAME CAUGHT ON THE DISTAL END OF THE STENT, CAUSING THE STENT TO BE STRETCHED ON THAT END. AN ADDITIONAL 8X40 MM ABSOLUTE PRO WAS IMPLANTED TO COVER THE STRETCHED PORTION OF THE STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162891 ↗
• InjuryApr 29, 2026Off-Label Use; Stretched; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY. THE 6.0X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT DELIVERY SYSTEM WAS ADVANCED. ONCE AT THE LESION, RESISTANCE WAS MET WITH THE THUMBWHEEL. THE STENT WAS DEPLOYED AT THE TARGET LESION; HOWEVER, THE STENT CAME OUT AS ONE LONG WIRE [STRETCHED/ELONGATED], SO AN UNSPECIFIED COVERED STENT WAS NEEDED TO PIN THE ABSOLUTE PRO STENT AGAINST THE LESION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033241 ↗
• MalfunctionApr 23, 2026Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A LEFT SUBCLAVIAN ARTERY. THE THUMBWHEEL OF THE 7.0X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT DELIVERY SYSTEM WAS DIFFICULT TO ROLL WHILE DEPLOYING, AND THE STENT WAS PARTIALLY DEPLOYED (FLOWERED) BUT WAS STILL ABLE TO BE REMOVED. A NEW UNSPECIFIED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO 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 24970472 ↗
• MalfunctionApr 21, 2026Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE 6.0X40 MM ABSOLUTE STENT WAS VERY HARD TO DEPLOY IN THE 100% STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS FLUSHED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. IT WAS ADVANCED OVER AN .035 GUIDEWIRE AND WAS VERY DIFFICULT TO MOVE THE THUMB WHEEL TO DEPLOY. THE STENT WAS SUCCESSFULLY DEPLOYED IN POSITION BUT WITH DIFFICULTY. 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 24943056 ↗
• MalfunctionApr 21, 2026Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE 6.0X100MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER DURING DEPLOYMENT THE THUMBWHEEL WAS DIFFICULT TO TURN AND THE STENT WAS DIFFICULT TO DEPLOY; HOWEVER ULTIMATELY DEPLOYED IN THE TARGET LESION. THERE WERE NO 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 24939703 ↗
• MalfunctionApr 16, 2026Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED EXTERNAL ILIAC ARTERY LESION. A 10X100 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER THE SHEATH WAS UNABLE TO BE RETRACTED AND THE STENT COULD NOT BE DEPLOYED. THE SES WAS REMOVED AND ANOTHER SAME SIZE ABSOLUTE PRO SES WAS ADVANCED TO THE TARGET LESION HOWEVER THE STENT WAS ONLY ABLE TO DEPLOY A THIRD OF THE WAY. THE SES WITH THE STENT WAS REMOVED AND THE PROCEDURE COMPLETED USING A NON-ABBOTT STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANALYSIS OF THE FIRST RETURNED DEVICE INDICATED THAT THE STENT IMPLANT WAS EXPOSED 2MM FROM THE DISTAL END OF THE SHEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899812 ↗
• MalfunctionApr 16, 2026Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED EXTERNAL ILIAC ARTERY LESION. A 10X100 MM ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER THE SHEATH WAS UNABLE TO BE RETRACTED AND THE STENT COULD NOT BE DEPLOYED. THE SES WAS REMOVED AND ANOTHER SAME SIZE ABSOLUTE PRO SES WAS ADVANCED TO THE TARGET LESION HOWEVER THE STENT WAS ONLY ABLE TO DEPLOY A THIRD OF THE WAY. THE SES WITH THE STENT WAS REMOVED AND THE PROCEDURE COMPLETED USING A NON-ABBOTT STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANALYSIS OF THE FIRST RETURNED DEVICE INDICATED THAT THE STENT IMPLANT WAS EXPOSED 2MM FROM THE DISTAL END OF THE SHEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899769 ↗
• MalfunctionApr 9, 2026Improper or Incorrect Procedure or Method; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 95% STENOSIS. THE 6X80 MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION VIA A COMMAND 18 GUIDE WIRE. THE DEVICE WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE THUMBWHEEL WOULD NOT ROTATE AND THE DEVICE COMPLETELY FAILED TO DEPLOY THE STENT. A 6X80 MM ABSOLUTE PRO VASCULAR SESS 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829968 ↗
• InjuryApr 8, 2026Stretched; Device Damaged by Another Device; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT EXTERNAL ILIAC ARTERY. THE 7X100 MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS DEPLOYED IN THE RIGHT EXTERNAL ILIAC AND THE SHEATH WAS ADVANCED IN ORDER TO PLACE AN OMNILINK ELITE STENT IN THE COMMON ILIAC ARTERY. THE SHEATH SNAGGED ON THE ABSOLUTE PRO STENT AND CAUSED THE STENT TO BECOME STRETCHED. THE OMNILINK STENT WAS ABLE TO BE DEPLOYED WITHOUT ISSUE AND AN ADDITIONAL STENT WAS USED IN THE EXTERNAL ILIAC TO COVER PART OF THE STRETCHED ABSOLUTE PRO STENT. THE PATIENT HAD A GREAT RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820958 ↗

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