VaPro Plus Pocket 71144Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00610075094479), received between Jan 24, 2025 and Jun 2, 2025 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN END USER WHO HAD BEEN USING THE HOLLISTER HYDRABALANCE CATHETER FOR SOME TIME WAS EXPERIENCING A BURNING SENSATION IN HIS URETHRA WHICH HADN'T SUBSIDED. IT WAS REPORTED THAT HE HAD A GERM IN HIS BLADDER AND HAD BEEN TAKING AN ANTIBIOTIC FOR THREE WEEKS.

  Patient problems: Dysuria; Urinary Tract Infection

  MAUDE report 22122100 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN END USER WHO IS A PARAPLEGIC, NOTICED SEDIMENT IN HIS URINE AND THEN 2 WEEKS LATER, DEVELOPED SYMPTOMS INCLUDING FEVER, ACHES, AND URINE LEAKAGE. IT WAS FURTHER REPORTED THAT THE PATIENT DIDN'T SEE A DOCTOR INITIALLY BECAUSE THE OFFICE WAS CLOSED BUT TOOK AN AT-HOME URINE TEST AND THEN TOOK THE ANTIBIOTIC CIPROFLOXACIN. IT WAS FURTHER REPORTED THE END USER KEEPS A SUPPLY OF ANTIBIOTICS AT HOME FOR SUCH CASES. IT WAS THEN REPORTED WHEN HE DID GET IN TO SEE A HEALTH CARE PROFESSIONAL TWO DAYS LATER, THE URINE TEST AT THE DOCTOR'S OFFICE WAS NEGATIVE. IT WAS REPORTED THE END USER CONTINUES TO TAKE THE ANTIBIOTIC (WHICH IS DAY AT 7 OF THE 14-DAY COURSE), AND THAT HIS FEVER IS DOWN BUT HE STILL LEAKS URINE AND HAS TO CATHETERIZE EVERY 200ML OTHERWISE HE LEAKS, AND BLADDER BECOMES OVERACTIVE. HE REPORTS HE STILL HAS SOME SEDIMENT IN URINE, BUT IT HAS DECREASED FROM THE AMOUNT HE HAD AT THE BEGINNING OF HIS SYMPTOMS.

  Patient problems: Fever; Urinary Frequency / Polyuria

  MAUDE report 21228452 ↗