ROM Plus®, Fetal Membranes Rupture Test ROM-5025Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814247020437), received between Apr 17, 2018 and Apr 17, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “False Positive Result” (1 report).

1 other recall cover devices cleared under the same FDA submission (K110605); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryApr 17, 2018False Positive Result

  PATIENT HAD A POSITIVE WHEN THE ROM PLUS TEST WAS USED. THE PATIENT WAS INDUCED AND ULTIMATELY TAKEN FOR A C-SECTION. DURING THE C-SECTION THE PHYSICIAN HAD TO RUPTURE THE MEMBRANES. THE BABY WAS TAKEN TO THE NICU DUE TO ISSUE FROM BEING PREMATURE.

  Patient problems: No Code Available

  MAUDE report 7437905 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110605. One submission often covers many models, so check the product and lot details in each record.

• Z-0541-2021 · Aug 13, 2020 · Terminated
  Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025