Absolute Pro 1012529-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648175633), received between Jul 30, 2018 and Sep 20, 2024 — classified as 1 injury, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2024Difficult or Delayed Activation; Physical Resistance/Sticking; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HIGHLY CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS PRE-DILATED WITH BALLOON CATHETERS AND ATHERECTOMY. THE 7.0X60MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE TARGET LESION HOWEVER RESISTANCE WAS NOTED DURING DEPLOYMENT, THE THUMBWHEEL WAS HARD TO TURN MAKING IT DIFFICULT TO DEPLOY THE STENT. 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 20266716 ↗
• MalfunctionMar 1, 2021Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT EXTERNAL ILIAC ARTERY VIA LEFT GROIN ACCESS. THE 7X60MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SES) WAS ADVANCED TO THE LESION AND UNLOCKED HOWEVER THE THUMB WHEEL WOULD NOT ROTATE, THEREFORE THE STENT WAS NOT IMPLANTED. THE DEVICE WAS REMOVED WITHOUT ISSUE. ANOTHER ABSOLUTE PRO SES WAS USED TO SUCCESSFULLY 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 11396919 ↗
• MalfunctionJan 22, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A WHITE FOREIGN MATERIAL WAS NOTED IN THE STERILE PACKAGING OF A 7.0 X 60 MM ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (SESS). THERE WAS NO REPORTED DAMAGE TO THE INNER POUCH OR THE SESS. THE INCIDENT OCCURRED DURING AN INSPECTION AT THE DISTRIBUTION CENTER. THE SESS WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS IDENTIFIED THE FOREIGN MATERIAL AS A POTENTIAL MANUFACTURING COMPONENT.

  Patient problems: No Patient Involvement

  MAUDE report 8269407 ↗
• MalfunctionJan 21, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INSPECTION OF A 7.0 X 60MM ABSOLUTE PRO VASCULAR DEVICE (CONSIGNMENT RETURN PRODUCT) AT A DISTRIBUTION CENTER, SEVERAL SMALL PIECES OF STRING LIKE WHITE FOREIGN MATERIAL WERE FOUND INSIDE THE STERILE POUCH. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS INDICATED THE STRANDS OF CLEAR MATERIAL REMOVED FROM THE SEALED POUCH WERE KYNAR (POLYVINYLIDENE FLUORIDE) FROM THE DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 8264241 ↗
• MalfunctionNov 29, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THERE WAS A PURPLE FOREIGN MATERIAL IN THE STERILE PACKAGING OF A 7.0 X 60 MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS). THERE WAS NO REPORTED DAMAGE TO THE INNER POUCH OR THE SESS. 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. RETURNED GOODS ANALYSIS IDENTIFIED THAT THE FOREIGN MATERIAL IN THE STERILE PACKAGING WAS A MANUFACTURING COMPONENT.

  Patient problems: No Patient Involvement

  MAUDE report 8116492 ↗
• 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 8062194 ↗
• InjuryOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 100% STENOSED LESION IN THE PATIENTS LOWER EXTREMITY. ON (B)(6) 2018, A 7X60MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM WAS DEPLOYED; HOWEVER, A COUPLE OF DAYS LATER THE PATIENT EXPERIENCED PAIN AND NUMBNESS IN BOTH LEGS, LEFT HIP PAIN, AND LEFT LEG DRAGS. THE PATIENT HAS NOTIFIED THE DOCTOR OF THESE DISCOMFORTS, BUT WAS TOLD THAT NOTHING IS WRONG. THE PATIENT CONTINUES TO EXPERIENCE THESE SYMPTOMS AND STATED THAT EVENT GETTING OUT OF BED IS HARD AND NOT DOABLE SOME DAYS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Numbness; Pain; Weakness

  MAUDE report 7991782 ↗
• MalfunctionJul 30, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING INCOMING INSPECTION OF A 7.0 X 60 MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS), DUST AND HAIR WAS OBSERVED INSIDE THE STERILE POUCH. THE SESS WAS NOT USED IN A PROCEDURE AS THIS WAS PART OF A CONSIGNMENT RETURN, AND THEREFORE THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7731602 ↗