inFlow Intraurethral Valve-Pump Sep 2016Recalls & reported problems
Vesiflo Inc · Urinary prosthesis, female, non-surgical · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08625630003027), received between Feb 19, 2019 and Feb 19, 2019 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Urinary Tract Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING IS A SUMMARY OF THE PATIENT'S HISTORY AS REPORTED BY THE PHYSICIAN: THE FEMALE PATIENT, AGE (B)(6) HAS SPINA BIFIDA AND AS A RESULT SHE DOES NOT HAVE THE ABILITY TO EMPTY HER BLADDER WITHOUT A BLADDER DRAINAGE DEVICE. SHE BEGAN USING THE INFLOW DEVICE IN (B)(6) 2016 AS HER BLADDER DRAINAGE METHOD. IN (B)(6) 2016, THE SECOND MONTH OF DEVICE USE, THE PATIENT PUSHED THE INFLOW DEVICE INTO HER URETHRA, WHICH THEN MIGRATED INTO HER BLADDER. IT WAS RETRIEVED SHORTLY THEREAFTER BY CYSTOSCOPE. THE PHYSICIAN REPORTED THAT THE DEVICE WAS INTACT AND APPEARED NORMAL. THE PATIENT STATED THAT SHE WANTED TO GO BACK ON DEVICE ON (B)(6) 2016 AND DID SO WITH PHYSICIAN APPROVAL. ON (B)(6) 2018 PATIENT VISITED HER PHYSICIAN'S OFFICE AND REPORTS THAT: SHE INSERTED INFLOW DEVICE INTO HER URETHRA ABOUT A MONTH AGO, SHE PUSHED IT FURTHER INTO HER URETHRA AND BELIEVES IT MIGRATED INTO HER BLADDER ABOUT 2 WEEKS AFTER SHE INSERTED IT, AND THE DEVICE HAS BEEN IN BLADDER AT LEAST 3 WEEKS (EST.). SHE REPORTS NO PAIN BUT THINKS SHE MIGHT HAVE UTI. NURSE PLACES A CATHETER TO ENABLE HER TO DRAIN HER BLADDER AND NOTES MALODOROUS, CLOUDY URINE DRAINING FROM BLADDER. INFLOW DEVICE WAS PALPATED IN THE BL
Patient problems: Urinary Tract Infection
MAUDE report 8350483 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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