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Elvie Pump 01Recalls & reported problems

Willow Innovations, Inc. · Power Breast Pump Model Number EP01 · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060442520035), received between Feb 23, 2022 and Feb 23, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Noise, Audible” (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

Device problems

  • Noise, Audible1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionFeb 23, 2022Noise, Audible

    I GOT AN ELVIE DOUBLE. ONE OF THE ELVIE PUMPS MAKES A CLICKING NOISE. I CONTACTED THE MANUFACTURER AS PRODUCT IS STILL UNDER WARRANTY. THE MANUFACTURER REFUSED TO FOLLOW UP AND INVESTIGATE AND ASSIST IN RESOLVING MATTER AND KEPT CLOSING THE COMPLAINT WITHIN DAYS. FDA SAFETY REPORT ID # (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 13592290 ↗

Other Pump, Breast, Powered devices

All Pump, Breast, Powered devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.