PREVENA RESTOR™ BELLA•FORM™ PRE5355Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849554007178), received between Sep 17, 2020 and Sep 17, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 17, 2025Class IIOpen, Classified

   Due to increase in complaints related to leak alarms

   Z-1175-2025 · Root cause: Device Design · Recall details · FDA record ↗

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.

• MalfunctionSep 17, 2020Therapeutic or Diagnostic Output Failure

  UPPER MIDDLE-AGED FEMALE WITH HISTORY OF BREAST CANCER. DURING SURGERY FOR RIGHT BREAST MASTECTOMY, SENTINEL NODE BX AND RECONSTRUCTION THE PUMP WOULD NOT STAY ON TO WORK. ANOTHER DEVICE OBTAINED, NO KNOWN HARM TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10546285 ↗