Willow Pump Kit 2.0, White PDW29Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00858298006293), received between Sep 25, 2019 and Mar 20, 2022 — classified as 5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2022Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  ON (B)(6) 2022, CUSTOMER REPORTED TO WILLOW CUSTOMER CARE THAT SHE DEVELOPED AN ABSCESS ON HER AREOLA (DATE OF OCCURRENCE IS AFTER (B)(6) 2022). IT IS UNCLEAR WHETHER OR NOT SHE WAS USING HER WILLOW PUMP DURING THE TIME THE ABSCESS DEVELOPED. AS OF (B)(6)2022, CUSTOMER'S ABSCESS HAD NOT FULLY HEALED.

  Patient problems: Abscess

  MAUDE report 13831689 ↗
• InjuryNov 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER'S MOTHER AND SISTER REPORTED TO (B)(6) CUSTOMER CARE ON 19 OCT 2020 THAT THE CUSTOMER HAD BEEN DIAGNOSED WITH AN INFECTION OF THE NIPPLE. THE CUSTOMER VISITED THE HOSPITAL AND WAS PRESCRIBED ORAL ANTIBIOTICS AND TOPICAL CREAM (MEDICATION DETAILS NOT PROVIDED).

  Patient problems: Skin Infection

  MAUDE report 10857107 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE ON (B)(6) 2020 THAT SHE WAS ADMITTED TO THE ER MULTIPLE TIMES AND DIAGNOSED WITH AN ABSCESS ON HER RIGHT BREAST. THE CUSTOMER WAS CONTACTED MULTIPLE TIMES FOR ADDITIONAL INFORMATION, BUT DID NOT RESPOND. CUSTOMER HAD USED WILLOW FOR MULTIPLE SESSIONS.

  Patient problems: Abscess

  MAUDE report 9887172 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE ON (B)(6) 2019 THAT SHE WAS TREATED FOR MASTITIS. SHE WAS TREATED BY HER PHYSICIAN WITH INTRAVENOUS ANTIBIOTICS. THE CUSTOMER HAD BEEN USING WILLOW FOR AT LEAST 3 DAYS PRIOR TO THE CONDITION DEVELOPING AND CONTINUED TO USE WILLOW FOR SEVERAL DAYS AFTERWARD. SHE CONTINUED PUMPING WITH AN ALTERNATE PUMP THROUGHOUT TREATMENT.

  Patient problems: Unspecified Infection

  MAUDE report 9614298 ↗
• InjurySep 25, 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 SHE WAS TREATED FOR MASTITIS. THE CUSTOMER REPORTED THAT DURING THE WEEK PRECEDING THE REPORTED MASTITIS, SHE WAS PUMPING WITH ANOTHER BREAST PUMP (MEDELA) AND PUMPED A SINGLE SESSION WITH WILLOW. THE CUSTOMER WENT TO THE ER, WAS PLACED ON AN INTRAVENOUS ANTIBIOTIC, HOSPITALIZED, AND PRESCRIBED AN ORAL ANTIBIOTIC. THE CUSTOMER IS COMPLETING 3 MORE DAYS OF ANTIBIOTICS AND CONTINUES TO BREAST PUMP WITH MEDELA. THE CUSTOMER DID NOT REPORT MASTITIS TO MEDELA.

  Patient problems: Unspecified Infection

  MAUDE report 9120375 ↗