Willow Pump Kit 2.0, Gray PDG30Recalls & reported problems
Willow Innovations, Inc. · Breast Pump · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00858298006309), received between Sep 6, 2019 and Jun 15, 2020 — classified as 2 injuries.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Laceration(s)1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE ON 24-FEB-2020 THAT SHE EXPERIENCED A SMALL CUT ON HER RIGHT NIPPLE ON (B)(6) 2020 FROM USING WILLOW WHICH HEALED WITHIN 4 DAYS. CUSTOMER STATED THAT SHE EXPERIENCES NO PAIN WHILE PUMPING. CUSTOMER WENT TO DOCTOR AND WAS PRESCRIBED A CREAM. THE NAME OF THE CREAM WAS NOT PROVIDED, AND REPEATED ATTEMPTS TO CONTACT CUSTOMER FOR ADDITIONAL INFORMATION WERE NOT ANSWERED.
Patient problems: Laceration(s)
MAUDE report 10156081 ↗InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE THAT ON (B)(6) 2019 THAT SHE WAS DIAGNOSED WITH MASTITIS. THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED FOR 7 DAYS AND PRESCRIBED THREE TYPES OF ANTIBIOTICS. SHE WAS PLACED ON AN INTRAVENOUS ANTIBIOTIC (CLEOCINE) AND AN ORAL ANTIBIOTIC (LINEZOLID). INFORMATION ON THE THIRD ANTIBIOTIC WAS NOT PROVIDED. THE CUSTOMER REPORTED THAT SHE WAS PUMPING WITH WILLOW AND ANOTHER BREAST PUMP (SPECTRA) DURING THE TIME OF THE REPORTED MASTITIS. THE MASTITIS HAS SINCE RESOLVED, AND THE CUSTOMER CONTINUES TO BREAST PUMP.
Patient problems: Unspecified Infection
MAUDE report 8972911 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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