Absolute Pro 1012530-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648175701), received between Aug 20, 2018 and Jun 3, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMar 23, 2026Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT EXTERNAL ILIAC ARTERY WITH MILD TORTUOSITY. THE 8 X 40 MM ABS PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE TARGET LESION ON A .035 NON-ABBOTT GUIDE WIRE. DURING STENT DEPLOYMENT THE THUMBWHEEL WAS JAMMING UP. HOWEVER, THE STENT ULTIMATELY ABLE TO BE DEPLOYED IN THE TARGET LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665207 ↗
• MalfunctionJan 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 8.0X40MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS), THE STENT IMPLANT WAS NOTED TO MOVE DISTALLY AND WAS LOOSE WHILE THE DEVICE WAS BEING WIPED DOWN. A NEW ABSOLUTE PRO SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23982371 ↗
• MalfunctionJan 11, 2023Difficult or Delayed Positioning; Premature Activation; Difficult or Delayed Positioning; Premature Activation

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

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16142390 ↗
• MalfunctionDec 29, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE EXTERNAL LEFT ILIAC ARTERY. THE ABSOLUTE PRO VASCULAR STENT WAS DEPLOYED, BUT AFTER DEPLOYMENT AND UNDER FLUOROSCOPY, IT WAS OBSERVED THAT THE STENT MISSED THE TARGET LESION BY 5 MM. THE DISTAL MARKERS OF THE STENT DID NOT MATCH UP WITH THE DISTAL MARKERS OF THE STENT DELIVERY SYSTEM. A 9X19 OMNILINK WAS DEPLOYED AT THE TARGET LESION TO COMPLETELY COVER THE LESION AND COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 11090451 ↗
• MalfunctionOct 15, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT COMMON FEMORAL ARTERY. AN 8.0X40MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION AND THE STENT PARTIALLY DEPLOYED. THE THUMBWHEEL THEN KEPT SPINNING BUT WOULD NO LONGER DEPLOY THE REST OF THE STENT. IT WAS ATTEMPTED TO PULL THE PARTIALLY DEPLOYED STENT AND DELIVERY SYSTEM BACK INTO THE SHEATH. WITH THAT MANIPULATION, THE SHEATH PULLED BACK THE DELIVERY SYSTEM AND THE STENT THEN FULLY DEPLOYED A LITTLE MORE DISTAL THAN INTENDED, BUT STILL WITHIN 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 Consequences Or Impact To Patient

  MAUDE report 9193804 ↗
• MalfunctionDec 28, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A WHITE FOREIGN MATERIAL WAS NOTED INSIDE THE PACKAGE OF AN 8.0 X 40 MM ABSOLUTE PRO VASCULAR STENT DELIVERY SYSTEM (SDS). THERE WAS NO DAMAGE NOTED IN THE INNER POUCH OR THE DEVICE ITSELF. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8203833 ↗
• MalfunctionNov 12, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INCOMING INSPECTION OF AN 7X60MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) A SMALL PIECE OF WHITE FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE POUCH. A SMALL PIECE OF BLACK FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE POUCH OF AN 8X40MM ABSOLUTE PRO VASCULAR SESS AND A SMALL PIECE OF PURPLE FOREIGN MATERIAL WAS FOUND INSIDE THE STERILE POUCH OF AN 8X100MM ABSOLUTE PRO VASCULAR SESS. THE INNER POUCHES WERE INTACT AND THE STERILITY OF THE DEVICES WAS NOT COMPROMISED. 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 8062212 ↗
• MalfunctionNov 9, 2018Difficult to Remove; Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult to Remove; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-TORTUOUS AND NON-CALCIFIED LESION IN THE LEFT EXTERNAL ILIAC ARTERY. AN ATTEMPT TO DEPLOY AN 8X40 MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS MADE; HOWEVER, HALF WAY THROUGH ADVANCING THE THUMBWHEEL IT BECAME STUCK AND WOULD NOT ROTATE. THE STENT WAS PARTIALLY DEPLOYED AND COULD NOT BE FULLY DEPLOYED DUE TO THE THUMBWHEEL NOT WORKING. AN ATTEMPT WAS MADE TO WITHDRAW THE STENT, BUT RESISTANCE WAS MET WITH THE ANATOMY AND THE STENT WAS PULLED OFF THE DELIVERY SYSTEM, DEPLOYING A LITTLE FURTHER BACK THAN INTENDED, BUT STILL AT THE INTENDED SITE. AN UNSPECIFIED BALLOON CATHETER WAS USED TO POST-DILATE THE STENT AS PART OF THE STANDARD PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8057612 ↗
• MalfunctionAug 28, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INCOMING INSPECTION AT THE DISTRIBUTION CENTER, WHITE FOREIGN MATERIAL WAS NOTED IN THE SEALED PACKAGING OF THE ABSOLUTE PRO VASCULAR STENT SYSTEM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7823649 ↗
• MalfunctionAug 20, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INCOMING INSPECTION OF AN 8X40MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) A SMALL PIECE OF WHITE FOREIGN PARTICLE WAS INSIDE THE STERILE POUCH. THE INCIDENT OCCURRED DURING AN INSPECTION OF A CONSIGNMENT RETURN AT THE DISTRIBUTION CENTER. THERE WAS NO DAMAGE TO THE INNER POUCH OR THE SESS AND THE STERILITY WAS NOT COMPROMISED. THE SESS WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS REVEALED THAT THE FOREIGN MATERIAL WAS A MANUFACTURING COMPONENT.

  Patient problems: No Patient Involvement

  MAUDE report 7799581 ↗