Sonata BreastpumpRecalls & reported problems across all models
Medela LLC · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls
- 0
We found 2 models of Sonata Breastpump by Medela LLC in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between May 17, 2017 and Mar 3, 2023 — classified as 32 injuries.
The most frequently reported specific device problem is “Decrease in Suction” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Sonata Breastpump problems
Device problems
- Decrease in Suction8
- Noise, Audible4
- Suction Problem4
- Adverse Event Without Identified Device or Use Problem3
- Gas/Air Leak3
- Charging Problem2
- Device Displays Incorrect Message2
- Premature Discharge of Battery2
Patient problems
- Unspecified Infection15
- Pain6
- Inflammation5
- No Known Impact Or Consequence To Patient5
- Bacterial Infection2
- No Code Available2
- Blood Loss1
- Fungal Infection1
Sonata Breastpump models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sonata Breastpump Sonata DeluxePump, Breast, Powered22 reports
- Sonata Breastpump Sonata DeluxePump, Breast, Powered10 reports
Recent Sonata Breastpump adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 3, 2023Failure to Power Up
ON 2/13/23, THE CUSTOMER ALLEGED TO MEDELA LLC WHILE USING HER SONATA BREAST PUMP IT WOULD NOT POWER ON, THE DISPLAY WOULD NOT SHOW THAT THE POWER CORD WAS PLUGGED IN. THE CUSTOMER STATED THE PUMP WS DROPPPED BEFORE THE ISSUE BEGAN. THE CUSTOMER ALSO ALLEGED THAT SHE DEVELOPED MASTITIS AND WAS PRESCRIBED ANTIBIOTICS TO TREAT IT.
Patient problems: Unspecified Infection
MAUDE report 16477004 ↗InjuryOct 6, 2021Gas/Air Leak
ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THERE WAS AN AIR LEAK MESSAGE ON HER SONATA BREAST PUMP AND SHE HAS NOT BEEN ABLE TO PUMP. SHE ALSO ALLEGED THAT SHE HAS MASTITIS, WAS DIAGNOSED BY HER DOCTOR, AND IS BEING PRESCRIBED ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 12583298 ↗InjuryAug 31, 2021Charging Problem
ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS HAVING BATTERY CHARGING ISSUES WITH HER SONATA BREAST PUMP. THE CUSTOMER ALSO ALLEGED THAT SHE DEVELOPED MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC.
Patient problems: Unspecified Infection
MAUDE report 12392906 ↗InjuryMar 26, 2021Decrease in Suction
ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER SONATA BREAST PUMP HAD LOW SUCTION AND SHE DEVELOPED MASTITIS LAST WEEK BUT IS OK NOW. IN FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2021, THE CUSTOMER INDICATED THAT SHE DEVELOPED MASTITIS PRIOR TO THE SUCTION ISSUE WITH THE BREAST PUMP AND WAS PRESCRIBED AN ANTIBIOTIC AND SAID SHE WAS ON THE MEND. (B)(6) 2021 BECOMES OUR AWARE DATE AS WE LEARNED THE CUSTOMER WAS PRESCRIBED ANTIBIOTICS TO TREAT HER MASTITIS.) THE CUSTOMER ALSO INDICATED THE MASTITIS HAD NOTHING TO DO WITH THE PUMP AND IT'S WAS BECAUSE SHE MESSED UP HER PUMPING SESSION THE NIGHT BEFORE.
Patient problems: Bacterial Infection
MAUDE report 11575186 ↗InjuryNov 11, 2020Suction Failure
ON 09/24/2020, THE CUSTOMER ALLEGED TO MEDELA (B)(4) THAT HER SONATA BREAST PUMP WAS NOT SUCTIONING CORRECTLY. SHE ALSO ALLEGED SHE WAS EXPERIENCING MASTITIS.
Patient problems: Unspecified Infection
MAUDE report 10822704 ↗InjuryOct 23, 2020Decrease in Suction
ON SEPTEMBER 28, 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER SONATA BREAST PUMP HAD LOW SUCTION, EVEN THOUGH SHE HAD TRIED REPLACING HER KIT PARTS. SHE ADDITIONALLY ALLEGED THAT SHE HAD MASTITIS AND HAD BEEN PRESCRIBED ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 10726808 ↗InjuryAug 26, 2020Suction Problem
ON 08/03/2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER SONATA BREAST PUMP. ADDITIONALLY, SHE ALLEGED THAT SHE DEVELOPED MASTITIS TWICE DUE TO THE LOW SUCTION AND RECEIVED ANTIBIOTICS FOR THE SECOND BOUT. THE CUSTOMER INDICATED THAT SHE ALSO HAS A PUMP IN STYLE BREAST PUMP THAT SHE WAS USING AND FELT SHE WAS ABLE TO EMPTY MORE MILK WITH IT THAN THE SONATA.
Patient problems: Unspecified Infection
MAUDE report 10455886 ↗InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem
ON 07/06/2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS FEELING PAIN IN HER BREAST WHEN PUMPING WITH HER SONATA BREAST PUMP, EVEN ON THE LOWEST VACUUM LEVEL, WHEN USING BOTH THE 24MM AND 27MM BREAST SHIELDS.
Patient problems: Pain
MAUDE report 10391953 ↗InjuryApr 27, 2020Detachment of Device or Device Component
ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA (B)(6) THAT THE POWER BUTTON FOR HER SONATA BREAST PUMP FELL INTO THE PUMP, THEREFORE SHE COULD NO LONGER TURN IT ON. SHE ADDITIONALLY ALLEGED THAT SHE HAD MASTITIS AND HAD TO PUMP EVERY TWO HOURS, WHICH REQUIRED HER TO PURCHASE ANOTHER SONATA BREAST PUMP IMMEDIATELY.
Patient problems: Unspecified Infection
MAUDE report 10001062 ↗InjuryApr 24, 2020Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER SONATA BREAST PUMP HAD NOT BEEN EXPRESSING HER MILK WELL, EVEN THOUGH THE SUCTION FELT STRONG ENOUGH. SHE INDICATED THAT IF SHE TURNED THE VACUUM LEVEL HIGHER, IT CAUSED HER NIPPLES TO CRACK AND BLEED, WHICH HAD TO BE TREATED WITH A PRESCRIPTION COMPOUND CREAM. SHE FURTHER ALLEGED THAT DUE TO USING THE PUMP WITHOUT PROPER EXPRESSION, SHE DEVELOPED MASTITIS, FOR WHICH SHE WAS TREATED WITH ANTIBIOTICS. SHE HAD BEEN PROPERLY MEASURED FOR BREAST SHIELDS, AND WAS USING THE SAME SIZE AS SHE HAD WITH HER PUMP IN STYLE BREAST PUMP, WHICH WORKS WITHOUT ISSUE AND HELPED HER TO CLEAR UP THE MASTITIS.
Patient problems: Blood Loss; Nipple Ulceration; Unspecified Infection
MAUDE report 9996297 ↗InjuryApr 10, 2020Inadequacy of Device Shape and/or Size
ON (B)(6) 2020, A DAD ALLEGED TO MEDELA LLC THAT A LACTATION CONSULTANT TOLD HIS DAUGHTER WHO WAS USING THE 21MM AND 24MM FLEX BREAST SHIELDS WITH HER SONATA BREAST PUMP THAT THEY WERE TOO SMALL. HE ADDITIONALLY ALLEGED THAT THEY CAUSED A LUMP IN HER BREAST, FOR WHICH HIS DAUGHTER WAS GOING TO VISIT THE DOCTOR.
Patient problems: No Code Available
MAUDE report 9947709 ↗InjuryApr 9, 2020Decrease in Suction
ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER SONATA BREAST PUMP WAS NOT CREATING ENOUGH SUCTION. SHE ADDITIONALLY ALLEGED THAT SHE WENT TO THE EMERGENCY ROOM ON (B)(6) 2020, AT WHICH TIME SHE WAS DIAGNOSED WITH MASTITIS ALONG WITH ANOTHER POTENTIAL INFECTION, FOR WHICH SHE WAS PRESCRIBED ANTIBIOTICS FOR 7 DAYS. THE PHYSICIAN INFORMED HER THAT SHE COULD NO LONGER USE THE BREAST PUMP NOR BREASTFEED.
Patient problems: Unspecified Infection
MAUDE report 9942729 ↗InjuryMar 27, 2020Device Displays Incorrect Message
ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER SONATA BREAST PUMP WAS SHOWING A CALL MESSAGE ON THE DISPLAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9887856 ↗InjuryFeb 17, 2020Device Displays Incorrect Message; Noise, Audible
ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER SONATA BREAST PUMP WAS DISPLAYING AN ERROR AND MAKING A LOUD NOISE. SHE ADDITIONALLY ALLEGED THAT SHE WAS IN PAIN BECAUSE SHE HAD NOT BEEN ABLE TO PUMP FOR TWO (2) DAYS AND HER BREASTS WERE ENGORGED, HOT, AND SORE.
Patient problems: Inflammation; Pain
MAUDE report 9717298 ↗InjuryFeb 4, 2020Charging Problem
ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE BATTERY FOR HER SONATA BREAST PUMP WAS NO LONGER HOLDING A CHARGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9666252 ↗
Other Medela LLC products
All Medela LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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