Pump Kit, Gen 3 (2S), 2PK, White, 24mm PDW48Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00858298006446), received between Jun 24, 2020 and Jan 28, 2022 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2022, THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE THAT SHE HAD VISITED HER DOCTOR FOR MASTITIS (INITIATED (B)(6)) WHICH LED TO SEPSIS. THE DOCTOR RECOMMENDED SHE USE ANOTHER PUMP TO EMPTY HER BREASTS. THE CUSTOMER DID NOT RESPOND TO FOLLOW UP REGARDING MEDICATIONS PRESCRIBED OR TREATMENT GIVEN, BUT STATED THAT "THE MEDICATION HAS CUT HER MILK SUPPLY." CUSTOMER STATED THAT SHE WOULD CONTINUE USING THE PUMP UNTIL SHE RECEIVED ANOTHER PUMP FROM HER INSURANCE.

  Patient problems: Sepsis

  MAUDE report 13387038 ↗
• InjuryJul 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 7/15/2021, THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE THAT SHE HAD BEEN SEEN BY A NURSE PRACTITIONER AND PRESCRIBED ORAL ANTIBIOTICS (DYNAPEN) ON (B)(6) 2021. SHE WAS SEEN BY AN OB/ GYN ON (B)(6) 2021 AND ADMITTED TO THE HOSPITAL. HER DIAGNOSIS WAS MASTITIS, SEPSIS, AND PYELONEPHRITIS. WHILE IN THE HOSPITAL, SHE WAS GIVEN IV ANTIBIOTICS (VANCOMYCIN, MEROPENEM, AND CLINDAMYCIN). UPON RELEASE, SHE WAS PRESCRIBED ORAL KEFLEX AND VANTIN. CUSTOMER WAS NOT ABLE TO BREASTFEED, HAND EXPRESS, OR PUMP. CUSTOMER HAS HEALED, BUT HAS THICKENED BREAST TISSUE WHICH REQUIRES FOLLOW-UP WITH A MAMMOGRAM.

  Patient problems: Kidney Infection; Sepsis; Skin Infection

  MAUDE report 12235711 ↗
• InjuryNov 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE ON 02 OCT 2020 THAT SHE HAD BEEN DIAGNOSED WITH THRUSH BY HER DOCTOR AND RECEIVED A PRESCRIPTION COMPOUNDED NIPPLE OINTMENT CONTAINING BETAMETHASONE, MICONAZOLE, MUPIROCIN, AND IN ADDITION, GENTIAN VIOLET.

  Patient problems: Skin Infection

  MAUDE report 10857099 ↗
• InjuryNov 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED TO (B)(6) CUSTOMER CARE ON (B)(6) 2020 THAT SHE EXPERIENCED A TEAR ON HER NIPPLE. THE CUSTOMER'S OB/ GYN PRESCRIBED A TOPICAL STEROID CREAM. THE CUSTOMER REPORTED PUMPING AS SHE HEALED.

  Patient problems: Skin Tears

  MAUDE report 10857026 ↗
• InjuryOct 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE ON (B)(6) 2020 THAT SHE EXPERIENCED MASTITIS. CUSTOMER VISITED URGENT CARE AND WAS TREATED INTRAVENOUSLY WITH AN UNKNOWN THERAPY, FOLLOWED BY AN ORAL ANTIBIOTIC. CUSTOMER CONTINUED PUMPING WITH AN ALTERNATIVE BREAST PUMP THROUGHOUT TREATMENT.

  Patient problems: Skin Infection

  MAUDE report 10623196 ↗
• InjuryOct 1, 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 EXPERIENCED THRUSH INFECTION WHICH BEGAN MID TO END OF (B)(6) (CUSTOMER UNSURE OF EXACT DATE) AND WAS TREATED BY A PRESCRIBED ANTIFUNGAL, DIFLUCAN, STARTING ON (B)(6) 2020. CUSTOMER CONTINUED PUMPING WITH AN ALTERNATIVE PUMP THROUGHOUT TREATMENT. CUSTOMER REPORTED THAT HER THRUSH INFECTION HAS RESOLVED.

  Patient problems: Skin Infection

  MAUDE report 10618204 ↗
• InjuryAug 23, 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-JUL-2020 THAT SHE HOSPITALIZED ON (B)(6) 2020 FOR SEPSIS SECONDARY TO MASTITIS. WHILE IN THE HOSPITAL, SHE WAS TREATED WITH WAS ON INTRAVENOUS VANCOMYCIN AND WAS GIVEN CLINDAMYCIN AT DISCHARGE ON (B)(6) 2020. CUSTOMER WAS HOSPITALIZED A SECOND TIME ON (B)(6) 2020 FOR (B)(6). SHE WAS DISCHARGED AFTER 3 DAYS WITH CONTINUED TREATMENT OF VANCOMYCIN VIA A PICC LINE. CUSTOMER NOTED PUMPING DURING TREATMENT USING AN ALTERNATE PUMP.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 10440548 ↗
• InjuryAug 19, 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)(67 2020 THAT SHE EXPERIENCED A RASH ON BOTH BREASTS IN THE LOCATION OF THE INSERTS. SHE WAS PRESCRIBED TRIAMCINOLINE 0.1% CREAM, THEN ORAL PREDNISONE. CUSTOMER HAS HEALED.

  Patient problems: Rash

  MAUDE report 10423881 ↗
• InjuryJul 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO (B)(6) CUSTOMER CARE ON 24 JUN 2020 THAT SHE HAD GONE TO THE HOSPITAL TWICE AND WAS PRESCRIBED ANTIBIOTICS FOR MASTITIS. CUSTOMER ALSO REPORTED THAT SHE DEVELOPED A BLISTER ON HER NIPPLE AND WAS PRESCRIBED A TOPICAL MEDICATION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10324181 ↗
• InjuryJul 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE ON 27 DEC 2019 THAT WILLOW WAS NOT EMPTYING HER BREASTS FULLY AND SHE HAD DEVELOPED MASTITIS AND WAS TREATED WITH ANTIBIOTICS. THE CUSTOMER REPORTED THAT SHE WENT TO THE EMERGENCY ROOM MULTIPLE TIMES ((B)(6) 2019 AND (B)(6) 2019) AND THAT ONE OF HER ANTIBIOTIC TREATMENTS CAUSED ANAPHYLAXIS.

  Patient problems: Unspecified Infection

  MAUDE report 10319493 ↗
• InjuryJul 23, 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 HAD BEEN DIAGNOSED WITH THRUSH FROM A LACTATION SPECIALIST AND THEN RECEIVED PRESCRIPTION ANTIFUNGAL FROM HER OB/GYN. SHE TOOK A 14 DAY ORAL DOSE OF FLUCONAZOLE AND A TOPICAL ANTIFUNGAL CREAM.

  Patient problems: Unspecified Infection

  MAUDE report 10312942 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE ON 16 JUN 2020 THAT WILLOW WAS NOT EMPTYING HER BREASTS FULLY AND SHE HAD EXPERIENCED MASTITIS. SHE WAS INITIALLY TREATED WITH ANTIBIOTICS AND DEVELOPED THRUSH, DUE TO A SENSITIVITY TO THE FIRST ANTIBIOTIC. A MILK CULTURE WAS TAKEN TO SELECT SUBSEQUENT ANTIBIOTICS FOR TREATMENT. CUSTOMER HAS ALSO RECEIVED TWO ULTRASOUNDS FOR DIAGNOSIS AND HEALING. SINCE THE FIRST ROUND OF ANTIBIOTICS DIDN'T CLEAR UP HER MASTITIS COMPLETELY, IT WAS RECOMMENDED THAT SHE WEAN IN ORDER TO RID HERSELF OF THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10292959 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE ON 28 MAY 2020 THAT SHE HAD EXPERIENCED SKIN BREAKDOWN AROUND THE NIPPLE WHICH LED TO MASTITIS. CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS TREATED WITH INTRAVENOUS ANTIBIOTICS (CEFTRIAXONE) AND WAS SENT HOME ON KEFLEX. SHE FAILED THE TREATMENT WITH KEFLEX AND WAS CHANGED TO AUGMENTIN. CUSTOMER IS AN EXCLUSIVE PUMPER WHO HAS STOPPED PUMPING AND HAS NOT YET HEALED.

  Patient problems: Unspecified Infection

  MAUDE report 10194859 ↗
• InjuryJun 24, 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 EXPERIENCED EXTREME DISCOMFORT AND EXCESSIVE PINCHING WHEN USING WILLOW CONTAINERS. CUSTOMER SOUGHT MEDICAL ADVICE FIRST VIA TELEPHONE, DUE TO COVID 19, AND WAS FIRST PRESCRIBED A COMPOUNDED OINTMENT, THEN ANTIBIOTICS. AFTER A WEEK OF NO RELIEF, SHE VISITED THE DOCTOR'S OFFICE AND WAS TOLD SHE HAD IRRITATION DUE TO THE PUMP. THE CUSTOMER CONTINUED TO PUMP WITH WILLOW BOTH DURING AND AFTER TREATMENT.

  Patient problems: Skin Irritation

  MAUDE report 10193216 ↗