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Swing Maxi 101043614Recalls & reported problems

Medela LLC · Double electric, single user breast pump intended to express & collect breast milk · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
8
Deaths reported
0
Injuries reported
8
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00020451436142), received between Feb 4, 2022 and Mar 15, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Suction Problem” (3 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Suction Problem3
  • Adverse Event Without Identified Device or Use Problem1
  • Charging Problem1
  • Decrease in Suction1
  • Insufficient Device Problem Information1
  • Patient-Device Incompatibility1
  • Power Problem1

Patient problems

  • Inflammation4
  • Unspecified Infection3

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 15, 2024Power Problem; Power Problem

    ON 3/10/2024, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER SWING MAXI BREAST PUMP WAS NOT HOLDING A CHARGE AND WOULD TURN OFF. ADDITIONALLY, SHE ALLEGED THAT SHE DEVELOPED MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC.

    Patient problems: Inflammation

    MAUDE report 18911115 ↗
  • InjuryDec 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

    ON 11/25/23, THE CUSTOMER EMAILED INTO MEDELA LLC STATING SHE HAD ISSUES WITH SWING MAXI PUMP. THE CUSTOMER ALSO ALLEGED SHE DEVELOPED MASTITIS TWICE DUE TO NOT BEING ABLE TO BREAST PUMP EFFECTIVELY.

    Patient problems: Inflammation

    MAUDE report 18266024 ↗
  • InjuryOct 31, 2023Suction Problem; Suction Problem

    ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER SWING MAXI BREAST PUMP. SHE HAD MASTITIS LAST WEEK AND TOOK ANTIBIOTICS FOR 10 DAYS.

    Patient problems: Inflammation

    MAUDE report 18039147 ↗
  • InjuryMay 2, 2023Suction Problem; Suction Problem

    ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER SWING MAXI HAD LOW SUCTION DUE TO WATER BUBBLES IN THE TUBING OF HER PUMP. ADDITIONALLY, SHE ALLEGED THAT SHE DEVELOPED MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC,

    Patient problems: Inflammation

    MAUDE report 16852893 ↗
  • InjuryAug 3, 2022Suction Problem

    ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA CANADA THAT HER SOLO BREAST PUMP HAD NO SUCTION. SHE ADDITIONALLY REPORTED SHE HAS MASTITIS AND IS ON ANTIBIOTICS. SHE WILL BE GOING TO HER DOCTOR TO GET AN ULTRASOUND.

    Patient problems: Unspecified Infection

    MAUDE report 15156991 ↗
  • InjuryMay 10, 2022Patient-Device Incompatibility

    ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE HAS FLAT NIPPLES AND HER SWING MAXI BREAST PUMP WAS NOT WORKING FOR HER. SHE ADDITIONALLY ALLEGED SHE HAD DEVELOPED MASTITIS FROM NOT BEING ABLE TO USE HER PUMP.

    Patient problems: Unspecified Infection

    MAUDE report 14348446 ↗
  • InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2022, THE CUSTOMER EMAILED MEDELA LLC AND ALLEGED THAT HER RECENTLY PURCHASED SWING MAXI BREAST PUMP SHE USED FOR A FULL DAY AND NIGHT WAS PAINFUL AND CAUSED CLOGGED DUCTS. SHE WENT TO THE HOSPITAL DUE TO HER BREAST BEING HARD.

    MAUDE report 13763723 ↗
  • InjuryFeb 4, 2022Decrease in Suction; Charging Problem

    ON (B)(6) 2021, THE CUSTOMER ALLEGED VIA EMAIL TO MEDELA LLC THAT SHE WAS HAVING CHARGING ISSUES WITH HER SWING MAXI BREAST PUMP. IT WAS WORKING VERY WELL BUT NOW HAS TO CHARGE IT EVERY 2 PUMPING SESSIONS. SHE ADDITIONALLY ALLEGED THAT HER BREAST PUMP WAS NOT PULLING AS EFFECTIVELY AS IT WAS BEFORE. SHE HAS AN INCREASED SUPPLY AND HAS DEVELOPED MASTITI.

    Patient problems: Unspecified Infection

    MAUDE report 13451124 ↗

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Sources and updates

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