VaPro Plus Pocket 71124Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00610075094462), received between May 2, 2025 and Jan 22, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2026Break

  IT WAS REPORTED THAT A 34-YEAR-OLD MALE END USER HAD BEEN USING THE HOLLISTER VAPRO PLUS POCKET DURING SELF-CATHETERIZATION AND REPORTED THAT A 7 TO 10 CM PIECE OF THE CATHETER BROKE OFF AND ENDED UP IN HIS BLADDER. IT WAS REPORTED THAT HE THEN WENT TO THE EMERGENCY ROOM AND WAS REPORTEDLY SCHEDULED FOR SURGERY THE NEXT DAY TO REMOVE THE BROKEN CATHETER PIECE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER FRAGMENT HAD REMAINED IN HIS BLADDER FROM A SATURDAY TO MONDAY, WHEN IT WAS SURGICALLY REMOVED.

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 24148567 ↗
• InjuryNov 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN END USER EXPERIENCED HEAVY BLEEDING AFTER USING HOLLISTER VAPRO CATHETERS. IT WAS FURTHER REPORTED THAT THREE CATHETERS LACKED LUBRICATION. IT WAS ADDITIONALLY REPORTED THAT THE END USER WAS HOSPITALIZED AND DIAGNOSED WITH A URINARY TRACT INFECTION, REQUIRING A 14-DAY COURSE OF ANTIBIOTICS. IT WAS ALSO REPORTED THAT THE URETHRA WAS IRRITATED WITH SIGNIFICANT BLEEDING; HOWEVER, THE PATIENT REFUSED PLACEMENT OF AN INDWELLING CATHETER AND CONSEQUENTLY MUST PERFORM SELF-CATHETERIZATION EVERY HOUR.

  Patient problems: Hematuria; Urinary Tract Infection

  MAUDE report 23604047 ↗
• InjuryMay 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 HAS BEEN USING THE VAPRO PLUS POCKET HYDRABALANCE INTERMITTENT URETHRAL CATHETER FOR APPROXIMATELY FOUR WEEKS, HAS HAD DIFFICULTY INSERTING THE CATHETER AND DESCRIBES A BURNING SENSATION IN THE URETHRA, OR RATHER, AN INFLAMMATION OF THE URETHRA. IT WAS FURTHER REPORTED THAT THE END USER SAW A UROLOGIST WHO PRESCRIBED AN ANTIBIOTIC, WHICH DID NOT IMPROVE THE CONDITION. IT WAS REPORTED THAT THE END USER FEELS IT IS GETTING WORSE AND WANTS TO COMPARE THIS CATHETER WITH ONE FROM ANOTHER MANUFACTURER.

  Patient problems: Dysuria

  MAUDE report 21949288 ↗