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
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
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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