ACTIVELIFE 175793Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00768455102631), received between Mar 1, 2022 and Feb 3, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (11 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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2025Malposition of Device; Malposition of Device

  THE END USER REPORTED THAT MOST OF THE APPLIANCES FROM THE TEN BOXES HAD OFF-CENTERED STARTER HOLES AND WERE NOT USABLE. THE END USER REPORTED THAT AS MOST OF THE STARTER HOLES WERE AFFECTED AND HE MUST SORT THROUGH THE BOXES TO FIND ONES THAT HE COULD USE. HE DID NOT USE THE PRODUCTS THAT WERE WITH OFF-CENTERED STARTER HOLES. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21295019 ↗
• MalfunctionFeb 3, 2025Malposition of Device; Malposition of Device

  THE END USER REPORTED THAT MOST OF THE APPLIANCES FROM THE TEN BOXES HAD OFF-CENTERED STARTER HOLES AND WERE NOT USABLE. THE END USER REPORTED THAT AS MOST OF THE STARTER HOLES WERE AFFECTED AND HE MUST SORT THROUGH THE BOXES TO FIND ONES THAT HE COULD USE. HE DID NOT USE THE PRODUCTS THAT WERE WITH OFF-CENTERED STARTER HOLES. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21295018 ↗
• MalfunctionFeb 3, 2025Malposition of Device; Malposition of Device

  THE END USER REPORTED THAT MOST OF THE APPLIANCES FROM THE TEN BOXES HAD OFF-CENTERED STARTER HOLES AND WERE NOT USABLE. THE END USER REPORTED THAT AS MOST OF THE STARTER HOLES WERE AFFECTED AND HE MUST SORT THROUGH THE BOXES TO FIND ONES THAT HE COULD USE. HE DID NOT USE THE PRODUCTS THAT WERE WITH OFF-CENTERED STARTER HOLES. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21295016 ↗
• MalfunctionFeb 3, 2025Malposition of Device; Malposition of Device

  THE END USER REPORTED THAT MOST OF THE APPLIANCES FROM THE TEN BOXES HAD OFF-CENTERED STARTER HOLES AND WERE NOT USABLE. THE END USER REPORTED THAT AS MOST OF THE STARTER HOLES WERE AFFECTED AND HE MUST SORT THROUGH THE BOXES TO FIND ONES THAT HE COULD USE. HE DID NOT USE THE PRODUCTS THAT WERE WITH OFF-CENTERED STARTER HOLES. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21295015 ↗
• MalfunctionFeb 3, 2025Malposition of Device; Malposition of Device

  THE END USER REPORTED THAT MOST OF THE APPLIANCES FROM THE TEN BOXES HAD OFF-CENTERED STARTER HOLES AND WERE NOT USABLE. THE END USER REPORTED THAT AS MOST OF THE STARTER HOLES WERE AFFECTED AND HE MUST SORT THROUGH THE BOXES TO FIND ONES THAT HE COULD USE. HE DID NOT USE THE PRODUCTS THAT WERE WITH OFF-CENTERED STARTER HOLES. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21295014 ↗
• MalfunctionFeb 3, 2025Malposition of Device; Malposition of Device

  THE END USER REPORTED THAT MOST OF THE APPLIANCES FROM THE TEN BOXES HAD OFF-CENTERED STARTER HOLES AND WERE NOT USABLE. THE END USER REPORTED THAT AS MOST OF THE STARTER HOLES WERE AFFECTED AND HE MUST SORT THROUGH THE BOXES TO FIND ONES THAT HE COULD USE. HE DID NOT USE THE PRODUCTS THAT WERE WITH OFF-CENTERED STARTER HOLES. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21295013 ↗
• MalfunctionFeb 3, 2025Malposition of Device; Malposition of Device

  THE END USER REPORTED THAT MOST OF THE APPLIANCES FROM THE TEN BOXES HAD OFF-CENTERED STARTER HOLES AND WERE NOT USABLE. THE END USER REPORTED THAT AS MOST OF THE STARTER HOLES WERE AFFECTED AND HE MUST SORT THROUGH THE BOXES TO FIND ONES THAT HE COULD USE. HE DID NOT USE THE PRODUCTS THAT WERE WITH OFF-CENTERED STARTER HOLES. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21295012 ↗
• MalfunctionFeb 3, 2025Malposition of Device; Malposition of Device

  THE END USER REPORTED THAT MOST OF THE APPLIANCES FROM THE TEN BOXES HAD OFF-CENTERED STARTER HOLES AND WERE NOT USABLE. THE END USER REPORTED THAT AS MOST OF THE STARTER HOLES WERE AFFECTED AND HE MUST SORT THROUGH THE BOXES TO FIND ONES THAT HE COULD USE. HE DID NOT USE THE PRODUCTS THAT WERE WITH OFF-CENTERED STARTER HOLES. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21295011 ↗
• MalfunctionFeb 3, 2025Malposition of Device; Malposition of Device

  THIS EMDR IS BEING SUBMITTED FOR AN ADDITIONAL UNKNOWN QUANTITY OF AFFECTED PRODUCTS FROM AN UNKNOWN NUMBER OF MARKET UNIT OF THE SAME LOT. THE END USER REPORTED THAT MOST OF THE APPLIANCES FROM THE TEN BOXES HAD OFF-CENTERED STARTER HOLES AND WERE NOT USABLE. THE END USER REPORTED THAT AS MOST OF THE STARTER HOLES WERE AFFECTED AND HE MUST SORT THROUGH THE BOXES TO FIND ONES THAT HE COULD USE. HE DID NOT USE THE PRODUCTS THAT WERE WITH OFF-CENTERED STARTER HOLES. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21295009 ↗
• MalfunctionFeb 3, 2025Malposition of Device; Malposition of Device

  THE END USER REPORTED THAT MOST OF THE APPLIANCES FROM THE TEN BOXES HAD OFF-CENTERED STARTER HOLES AND WERE NOT USABLE. THE END USER REPORTED THAT AS MOST OF THE STARTER HOLES WERE AFFECTED AND HE MUST SORT THROUGH THE BOXES TO FIND ONES THAT HE COULD USE. HE DID NOT USE THE PRODUCTS THAT WERE WITH OFF-CENTERED STARTER HOLES. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294960 ↗
• MalfunctionFeb 3, 2025Malposition of Device; Malposition of Device

  THE END USER REPORTED THAT MOST OF THE APPLIANCES FROM THE TEN BOXES HAD OFF-CENTERED STARTER HOLES AND WERE NOT USABLE. THE END USER REPORTED THAT AS MOST OF THE STARTER HOLES WERE AFFECTED AND HE MUST SORT THROUGH THE BOXES TO FIND ONES THAT HE COULD USE. HE DID NOT USE THE PRODUCTS THAT WERE WITH OFF-CENTERED STARTER HOLES. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294959 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL NURSE THAT END USER HAD BEEN USING THIS PRODUCT FROM ALMOST TWENTY TWO YEARS WITH USUAL WEAR-TIME OF FIVE DAYS. ON (B)(6) 2022, HE REPORTED ABOUT AN APPLIANCE THAT HE HAD FOR APPROXIMATELY THREE YEARS. CONSUMER STATED THAT HE DEVELOPED A URINARY TRACT INFECTION SEVERAL HOURS AFTER USING THE APPLIANCE. HE REPORTED THERE WAS NOTHING DIFFERENT OR UNUSUAL ABOUT THE PRODUCT'S APPEARANCE. HE EXPERIENCED CHILLS, SWEATS, AND DARK CONCENTRATED URINE (NO ODOR). CONSUMER SUSPECTED THAT IT WAS DUE TO THE PRODUCT SINCE HE HAD IT ON HAND FOR ABOUT THREE YEARS. HE ALSO REPORTED THAT THE APPLIANCE WAS STORED IN A DRY PLACE. HE SAW HIS UROLOGIST PAST WEEK WHO PRESCRIBED HIM CIPROFLOXACIN FOR HIS URINARY TRACT INFECTION. CONSUMER FELT THAT THE APPLIANCE MIGHT HAVE CAUSED THE INFECTION, BUT THE DOCTOR DID NOT CONFIRM. CONSUMER EXPERIENCED CHRONIC URINARY TRACT INFECTION WHICH HE STATED WERE BECOMING MORE FREQUENT. THERE WAS NO CAUSE DETERMINED BY HIS DOCTOR, BUT HE FOLLOWED UP AGAIN WITH UROLOGIST WHO DID NOT DETERMINE AN EXACT CAUSE OF HIS CURRENT URINARY TRACT INFECTION. THE UROLOGIST DID NOT CONFIRM THAT POUCH CAUSED THE INFECTION. HE HAD A HISTORY OF FRE

  Patient problems: Chills; Diaphoresis; Urinary Tract Infection

  MAUDE report 13633945 ↗