Sonata Breastpump Sonata Deluxe (REF 101037319)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00020451367507), received between Apr 10, 2020 and Mar 3, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Decrease in Suction” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, 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 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 ↗