Willow Replacement Pump 2.0, White PRW31Recalls & reported problems
Willow Innovations, Inc. · Replacement Pump · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858298006187), received between Mar 20, 2022 and Mar 20, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Skin Infection1
- Skin Tears1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2022, THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE THAT ON (B)(6) 2021 SHE HAD EXPERIENCED INJURY TO HER NIPPLE TISSUE. HER OB/GYN PRESCRIBED ORAL ANTIBIOTICS DUE TO INFECTION (2 ROUNDS). CUSTOMER STATED THAT SHE WOULD NO LONGER BE ABLE TO BF, AND MAY NEED TO HAVE CORRECTIVE SURGERY. CUSTOMER STATED THAT HER INITIAL INJURY HEALED, ALTHOUGH NOT PROPERLY. AFTER THE INJURY, SHE STATED THAT SHE WAS STILL PUMPING, USING ONE PUMP. NO FURTHER FOLLOW UP WAS PROVIDED.
Patient problems: Skin Infection; Skin Tears
MAUDE report 13831801 ↗
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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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