Willow Breast Pump PDW00Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00858298006002), received between Feb 28, 2018 and May 31, 2018 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  WHILE IN COMMUNICATION WITH THE CUSTOMER ON (B)(6) 2018, THE CUSTOMER REPORTED THAT SHE HAD MASTITIS IN HER LEFT BREAST AND WAS PRESCRIBED ANTIBIOTICS BUT WAS CONTINUING TO PUMP WITH WILLOW.

  Patient problems: Unspecified Infection

  MAUDE report 7557827 ↗
• InjuryMay 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  WHILE IN COMMUNICATION WITH THE CUSTOMER ON (B)(6) 2018, THE CUSTOMER REPORTED THAT SHE HAD MASTITIS AND WAS PRESCRIBED ANTIBIOTICS BUT WAS CONTINUING TO PUMP WITH WILLOW.

  Patient problems: Unspecified Infection

  MAUDE report 7557747 ↗
• InjuryMay 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE THAT SHE HAD DEVELOPED MASTITIS AFTER BECOMING ENGORGED WHILE USING WILLOW BREAST PUMP. THE CUSTOMER'S PHYSICIAN PRESCRIBED HER ANTIBIOTICS AS TREATMENT FOR HER MASTITIS, WHICH HAS SINCE RESOLVED, AND THE CUSTOMER DISCONTINUED USE OF WILLOW.

  Patient problems: Unspecified Infection

  MAUDE report 7515555 ↗
• InjuryApr 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, THE CUSTOMER REPORTED TO EXPLORAMED NC7 THAT SHE DEVELOPED MASTITIS ON (B)(6) 2018 AFTER USING WILLOW FOR 45 MINUTES. HER PHYSICIAN SAID THE MASTITIS WAS CAUSED BY PUMPING TOO LONG AND PRESCRIBED THE USER ANTIBIOTICS. THE MASTITIS HAS SINCE RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 7430671 ↗
• InjuryApr 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING COMMUNICATION WITH THE CUSTOMER ON (B)(4) 2018, THE CUSTOMER STATED THAT HER LACTATION CONSULTANT RECOMMENDED THAT SHE SEE HER PHYSICIAN AS SHE FELT SHE WAS IN THE BEGINNING STAGES OF MASTITIS. THE PHYSICIAN PRESCRIBED HER ANTIBIOTICS AS TREATMENT FOR HER MASTITIS, WHICH HAS SINCE RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 7430670 ↗
• InjuryMar 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, THE CUSTOMER REPORTED TO EXPLORAMED NC7 THAT SHE HAD DEVELOPED MASTITIS WHILE USING WILLOW. THE MANUFACTURER CONTACTED THE USER, AND ON (B)(6) 2018, THE MANUFACTURER LEARNED THAT THE MASTITIS OCCURRED IN (B)(6) 2017. THE USER WAS PRESCRIBED ANTIBIOTICS FOR HER MASTITIS, WHICH HAS SINCE RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 7339606 ↗
• InjuryFeb 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE CUSTOMER REPORTED TO EXPLORAMED NC7 THAT SHE ALLEGEDLY DEVELOPED MASTITIS WHILE USING WILLOW. ON (B)(6) 2018, SHE REPORTED THAT SHE WAS PRESCRIBED ANTIBIOTICS FOR HER MASTITIS AND THE MASTITIS WAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 7304944 ↗