Absolute Pro 1012535-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648176067), received between Apr 10, 2017 and Jul 28, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Premature Activation; Premature Activation

  IT WAS REPORTED DURING THE PROCEDURAL PREPARATION OF A 7X40MM ABSOLUTE PRO SELF-EXPANDING STENT (SES) THAT THE STENT STRUTS WERE NOTED TO BE PARTIALLY EXPOSED AND FLOWERED, THEREFORE THE SES WAS REPLACED WITH ANOTHER STENT AND THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT INVOLVEMENT NOR CLINICAL DELAY REPORTED. THE DEVICE WAS RECEIVED AND THE RETURN ANALYSIS REVEALED THAT THE SES WAS RETURNED WITH BLOOD IN THE STENT SHEATH, IN THE RETRACTING SHEATH, IN THE INNER MEMBER, AND ON THE DEVICE. THE ACCOUNT STATES THAT THE ABSOLUTE PRO WAS NOT ADVANCED NOR CONNECTED TO ANY DEVICE THAT WAS INSIDE THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637146 ↗
• MalfunctionMar 25, 2025Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE EXTERNAL ILIAC ARTERY. DURING THE DEPLOYMENT OF A 7X40MM ABSOLUTE PRO SELF-EXPANDING STENT (SES) THE THUMBWHEEL WAS NOTED TO BE DIFFICULT TO ROTATE AND THE STENT WAS DIFFICULT TO FULLY DEPLOY. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21690286 ↗
• MalfunctionJan 16, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT PRIOR TO USE OF THE 7 X 40 MM ABS PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS), THE STENT WAS NOTED TO EXPOSED AND NOT FLOWERED. THEREFORE, THE SESS WAS NOT USED IN THE PROCEDURE. ANOTHER SAME SIZE ABS 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 21171939 ↗
• MalfunctionJul 17, 2024Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE 7.0X40MM ABSOLUTE PRO SELF-EXPANDING STENT BEGAN TO PARTIALLY DEPLOY DURING PREPARATION UPON REMOVING THE STYLET. ANOTHER ABSOLUTE PRO STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763123 ↗
• MalfunctionNov 14, 2022Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 7.0X40MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) FELT RESISTANCE WITH THE THUMB WHEEL UPON DEPLOYMENT, BUT WAS ABLE TO SUCCESSFULLY DEPLOY THE STENT. THERE WAS NO ADVERSE PATIENT EFFECT 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 15793993 ↗
• MalfunctionSep 19, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT AFTER REMOVAL OF A 7X40MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) FROM ITS PACKAGING, WHEN ATTEMPTING TO REMOVE THE STYLET, A SMALL PORTION OF THE STENT BECAME EXPOSED AND PARTIALLY FLOWERED OUTSIDE OF THE HOUSING. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15449668 ↗
• MalfunctionAug 22, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE ABSOLUTE PRO VASCULAR STENT DELIVERY SYSTEM WAS REMOVED FROM THE HOOP WITHOUT DIFFICULTY. THE STYLET WAS REMOVED WITHOUT DIFFICULTY. IT WAS NOTED THAT THE STENT WAS EXPOSED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272172 ↗
• MalfunctionSep 3, 2021Premature Activation; Difficult to Remove; Premature Activation; Difficult to Remove

  IT WAS REPORTED THAT PRIOR TO USE IN THE PATIENT DURING REMOVAL OF THE STYLET, SOME RESISTANCE WAS FELT AND THE TIP STUCK TO THE STYLET. DURING STYLET REMOVAL, THE 7.0X40 MM ABSOLUTE PRO STENT BEGAN DEPLOYING. TWO CELLS OF THE STENT WERE DEPLOYED. SINCE THERE WAS NO PATIENT INVOLVEMENT, ANOTHER SAME SIZE ABSOLUTE PRO WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422430 ↗
• MalfunctionApr 21, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE RIGHT EXTERNAL ILIAC ARTERY. AN ABSOLUTE PRO STENT ADVANCED AND STENT DEPLOYMENT WAS PERFORMED WITHOUT ISSUES NOTED AT THAT TIME. FOLLOWING, AN ARMADA DILATATION CATHETER ADVANCED AND POST-DILATATION WAS PERFORMED WITHOUT ISSUES REPORTED. DURING ARMADA REMOVAL, RESISTANCE WAS MET. IT WAS THEN OBSERVED THAT THE ABSOLUTE PRO STENT HAD PARTIALLY DEPLOYED AT THE TARGET LESION AND PARTIALLY DEPLOYED IN THE SHEATH. THE ARMADA CATHETER HAD BECOME STUCK IN THE SHEATH AND IN THE PARTIALLY DEPLOYED ABSOLUTE PRO STENT. ALL WAS REMOVED, PARTIALLY DEPLOYED STENT, SHEATH, AND ARMADA CATHETER, AS A SINGLE UNIT. ANGIOPLASTY WAS PERFORMED ON THE TARGET LESION IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700885 ↗
• InjurySep 25, 2018Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. A 7.0X40MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM WAS ADVANCED TO THE TARGET LESION AND DEPLOYED WITHOUT ISSUE. ANGIOGRAPHY AFTER DEPLOYMENT REVEALED THAT THE STENT WAS FRACTURED. THE STENT WAS POST-DILATED WITH AN UNSPECIFIED BALLOON DILATATION CATHETER, AND A 7.0X30MM ABSOLUTE PRO VASCULAR STENT WAS THEN DEPLOYED TO COVER THE STENT FRACTURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7907049 ↗
• MalfunctionSep 7, 2018Difficult to Advance; Mechanical Jam; Activation Failure; Difficult to Advance; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DISTAL LESION BELOW THE BIFURCATION OF THE POPLITEAL ARTERY WITH CALCIFICATION AND NO TORTUOSITY. A 6F SHEATH WAS PLACED AND THE LESION WAS PRE-DILATED WITH AN UNSPECIFIED BALLOON DILATATION CATHETER. A 7.0MM X40 MM X 135CM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED WITH SLIGHT RESISTANCE FROM THE ANATOMY. ON DEPLOYMENT OF THE STENT OF THE SESS, THE THUMBSLIDE [THUMBWHEEL] BECAME STUCK AND WOULD NOT MOVE. THE STENT OF THE SESS DID NOT APPEAR EXPOSED ON IMAGING AND THE SESS WAS THEREFORE REMOVED FROM THE PATIENT ANATOMY. NO RESISTANCE ON REMOVAL WAS FELT. OUTSIDE OF THE ANATOMY, THE DISTAL END OF THE STENT WAS NOTED TO BE EXPOSED AND THE THUMBSLIDE [THUMBWHEEL] REMAINED STUCK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT STENT. THERE WAS 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 7855598 ↗
• InjuryApr 10, 2017Detachment Of Device Component; Positioning Failure; Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. AFTER POSITIONING A 6FR NON-ABBOTT GUIDING SHEATH, A 7.0 MM X 40 MM X 135 CM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED VIA THE LEFT COMMON FEMORAL ARTERY, UP AND OVER TO THE TARGET LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. THE ABSOLUTE PRO STENT WAS DIFFICULT TO VISUALIZE UNDER FLUOROSCOPY AND THOUGHT TO BE POSITIONED IN THE TARGET LESION; WHEN RELEASING THE STENT, IT WAS DISCOVERED THAT THE PROXIMAL HALF OF THE STENT HAD RELEASED INSIDE OF THE GUIDING SHEATH. THE SHEATH, GUIDE WIRE, AND PARTIALLY DEPLOYED STENT WERE WITHDRAWN AS A SINGLE UNIT, WITH RESISTANCE FELT BUT NO VESSEL DAMAGE NOTED. HOWEVER, WHEN REACHING THE LEFT COMMON FEMORAL ARTERY, THE PORTION OF THE ABSOLUTE PRO STENT THAT WAS PROTRUDING BROKE OFF / SEPARATED IN THE VESSEL. THE SEPARATED STENT PORTION WAS SUCCESSFULLY SURGICALLY REMOVED AND TREATMENT OF THE TARGET LESION WAS RESCHEDULED FOR (B)(6) 2017. THE PATIENT RETURNED FOR TREATMENT OF THE TARGET LESION ON (B)(6) 2017. A 9.0 MM X 60 MM X 80 CM ABSOLUTE PRO VASCULAR SESS WAS ADVANCED VIA THE RIGHT COMMON FEMORAL ARTERY. THIS A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6476272 ↗