Willow Breast Pump, Gray PDG01Recalls & reported problems
Willow Innovations, Inc. · Breast Pump · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00858298006019), received between May 17, 2018 and Nov 4, 2020 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection2
- Blister1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE ON (B)(6) 2020 THAT SHE WAS EXPERIENCING BLOOD BLISTERS. CUSTOMER SPOKE TO HER OB/GYN AND WAS PRESCRIBED A TOPICAL ANTIBIOTIC (GENTAMICIN SULFATE OINTMENT USP .1%) TO PREVENT INFECTION AND HELP THE SKIN HEAL FASTER.
Patient problems: Blister
MAUDE report 10783379 ↗InjuryMay 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2018, THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE THAT ON (B)(6) 2018 SHE HAD A FEVER AND WENT TO SEE HER PHYSICIAN. HER PHYSICIAN DIAGNOSED HER WITH MASTITIS AND PRESCRIBED ORAL ANTIBIOTICS AS TREATMENT. ON (B)(6) 2018, 28 DAYS AFTER THE INITIAL ONSET OF MASTITIS, THE CUSTOMER REPLIED TO EARLIER FOLLOW-UP ATTEMPTS BY WILLOW CUSTOMER CARE AND SHE REPORTED THAT THE INITIAL PRESCRIPTION OF ANTIBIOTIC MEDICATION HAD BEEN INEFFECTIVE IN IMPROVING HER CONDITION. SHE WAS ADMITTED AND PLACED ON AN INTRAVENOUS ANTIBIOTIC FROM (B)(6) 2018. THE MASTITIS HAS SINCE RESOLVED AND THE CUSTOMER CONTINUES TO BREAST FEED AND BREAST PUMP.
Patient problems: Unspecified Infection
MAUDE report 7538212 ↗InjuryMay 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2018, THE USER'S HUSBAND REPORTED TO WILLOW CUSTOMER CARE THAT HIS WIFE HAD DEVELOPED MASTITIS WHILE USING WILLOW BREAST PUMP. THE CUSTOMER'S PHYSICIAN PRESCRIBED HER ANTIBIOTICS AS TREATMENT FOR HER MASTITIS, WHICH HAS SINCE RESOLVED. SHE HAS DISCONTINUED USE OF WILLOW.
Patient problems: Unspecified Infection
MAUDE report 7523992 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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