Revive 0025Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00854389008009), received between Jan 13, 2025 and Jan 13, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K183468); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WENT TO THE EMERGENCY ROOM DUE TO EXPERIENCING BLEEDING AND PAIN. SHE WAS DIAGNOSED WTIH A PERINEUM HEMATOMA, WHICH THE PHYSICICAN CONTRIBUTED TO THE BLEEDING THAT I EXPERIENCED FROM WEARING THE DEVICE 2 WEEKS AGO. THE PATIENT INDICATED THAT SHE ALSO EXPEREIENCED A URINARY TRACT INFECTION WHICH OCCURED AFTER THE FIRST COUPLE OF USES. THE LAST TIME SHE USED THE PRODUCT WAS 2 WEEKS PRIOR TO THE INCIDENT.·

  Patient problems: Genital Bleeding; Hematoma; Pelvic Pain; Perineal injury

  MAUDE report 21146119 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183468. One submission often covers many models, so check the product and lot details in each record.

• Z-1952-2019 · May 2, 2019 · Terminated
  Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage caused by stress urinary inconti