VaPro Plus Pocket 71144-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00610075065332), received between Jul 24, 2023 and Sep 17, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN END USER EXPERIENCED SEVERAL EPISODES WHERE HIS CATHETERIZED URINE WOULD LOOK DARK GREY, ALMOST BLACK IN COLOR AS SEEN IN THE COLLECTION BAG OF THE HOLLISTER VAPRO PLUS POCKET INTERMITTENT HYDROPHILIC CATHETER PRODUCT. IT WAS REPORTED THAT THIS WOULD HAPPEN DURING A CATHETERIZATION AND THEN THE NEXT CATHETERIZATION, THE URINE WOULD GO BACK TO NORMAL AGAIN (LIGHT YELLOW WITHOUT CLOUDINESS). IT WAS REPORTED THAT THE END USER WENT TO URGENT CARE AND WAS TOLD IT WAS NOT A HOLLISTER ISSUE BUT RATHER A MEDICAL MATTER OF ON AGAIN OFF AGAIN INTERNAL BLEEDING, DESPITE NOT EXPERIENCING ANY PAIN, DISCOMFORT OR ANY OTHER PHYSICAL SYMPTOMS. IT WAS FURTHER REPORTED THAT THE END USER WAS PRESCRIBED ANTIBIOTICS. IT WAS REPORTED THAT THE END USER WILL MAKE AN APPOINTMENT TO SEE HIS DOCTOR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20235499 ↗
• InjuryApr 9, 2024Break; Break

  IT WAS REPORTED THAT A NURSE WHO WAS CATHETERIZING A MALE PATIENT WITH A HOLLISTER VAPRO URINARY CATHETER TO COLLECT URINE FOR A URINALYSIS OBSERVED THAT PART OF THE CATHETER APPEARED MISSING WHEN WITHDRAWN FROM THE PATIENT'S URETHRA. IT WAS REPORTED THAT THE NURSE INSERTED THE CATHETER WITHOUT ANY DIFFICULTY AND ATTEMPTED TO WITHDRAW IT APPROXIMATELY 5 MINUTES LATER WHEN THERE WAS SOME RESISTANCE AND SHE HAD TO USE A LITTLE FORCE TO REMOVE IT. IT WAS REPORTED THAT POST-CATHETERIZATION, THE DOCTOR ORDERED A CT SCAN AND THEN PERFORMED A CYSTOSCOPY. IT WAS REPORTED THAT HE REMOVED A CATHETER FRAGMENT APPROXIMATELY 9 INCHES LONG FROM THE PATIENT'S BLADDER. IT WAS FURTHER REPORTED THAT HE ORDERED THE USE OF A FOLEY FOR 24 HOURS POST PROCEDURE. IT WAS REPORTED THAT THE DOCTOR DID NOT SAVE OR TAKE A PICTURE OF THE CATHETER FRAGMENT BUT REPORTED THAT IT LOOKED LIKE A CLEAN BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19071839 ↗
• InjuryJan 23, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER THE HOLLISTER VAPRO PLUS POCKET HYDROPHILIC INTERMITTENT CATHETER WAS INSERTED AND REMOVED FROM THE URETHRA, THERE WAS SELF-LIMITING BLOOD UPON REMOVAL OF THE CATHETER. IT WAS FURTHER REPORTED THAT TWO DAYS LATER AN INFECTION DEVELOPED WITH LOWER ABDOMINAL PAIN AND PURULENT DISCHARGE. IT WAS REPORTED THAT THE END USER DID NOT SEEK MEDICAL ATTENTION FOR THIS EVENT AND THIS OBSERVATION WAS SELF-REPORTED BY THE END USER. IT WAS REPORTED THAT HE USED ANTIBIOTICS FOR THIS EVENT THAT WAS PRESCRIBED FOR HIM PREVIOUSLY FOR TREATMENT OF A FUTURE UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 18562049 ↗
• InjuryOct 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER THE HOLLISTER VAPRO PLUS POCKET HYDROPHILIC INTERMITTENT CATHETER WAS INSERTED FOR ABOUT 3 MINUTES, THE NURSE TRIED TO REMOVE IT AND IT WAS STUCK. IT WAS REPORTED THAT THE NURSE HAD THE CHARGE NURSE COME TO ASSIST HER AND THEY HAD TO PULL VERY HARD TO REMOVE IT. IT WAS FURTHER REPORTED THAT ABOUT 24 HOURS LATER THE END USER DEVELOPED A UTI AND HAD TO BE READMITTED TO THE ACUTE HOSPITAL FOR TREATMENT.

  Patient problems: Urinary Tract Infection

  MAUDE report 17903812 ↗
• InjuryJul 24, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE END USER WAS HOSPITALIZED FOR UROSEPSIS. IT WAS REPORTED THAT THE END USER'S WIFE, WHO CATHETERIZES THE PATIENT, STATED THAT THE COLLECTION BAGS WERE LEAKING FROM A POTENTIAL HOLE OR EDGE SEAL FAILURE. THE USER'S WIFE ALSO REPORTED THAT THE CATHETER'S NO TOUCH SLEEVE PULLS LIKE CHEWING GUM, TEARS, AND LEAKS. THERE WAS NO ALLEGATION OF CONTAMINATION. IT WAS FURTHER REPORTED BY THE WIFE THAT THERE WAS NOTHING WRONG WITH THE CATHETERS THEMSELVES AND THE URINE WAS ABLE TO BE DRAINED AS INTENDED. THE TREATMENT REPORTED BY THE WIFE WAS WITH HIGH DOSES OF ANTIBIOTICS AND THEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Sepsis

  MAUDE report 17378813 ↗