Sonata Breastpump Sonata Deluxe (UDI 00020451582009)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00020451582009), received between May 17, 2017 and Aug 26, 2020 — classified as 22 injuries.

The most frequently reported specific device problem is “Decrease in Suction” (6 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryNov 7, 2019Device Alarm System

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER REPLACEMENT SONATA BREAST PUMP WAS DISPLAYING AN 4A98 ERROR WHICH SHE COULD NOT CLEAR, EVEN AFTER REBOOTING THE PUMP. SHE ADDITIONALLY ALLEGED THAT SHE HAD MASTITIS.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 9292284 ↗
• InjuryAug 22, 2019Leak/Splash

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT IN ORDER TO RESOLVE A LEAK ERROR, SHE HAD TO INCREASE THE VACUUM ON HER SONATA BREAST PUMP, AND WHEN SHE DID SO, IT CAUSED PAIN AND CUTS ON HER NIPPLES.

  Patient problems: Laceration(s); Pain

  MAUDE report 8921553 ↗
• InjuryAug 15, 2019Suction Problem

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT AFTER PUMPING WITH HER SONATA BREAST PUMP, SHE FELT AS IF SHE STILL HAD MILK TO PUMP FROM HER BREASTS, AS IT DID NOT SEEM AS IF THE PUMP WAS EMPTYING ALL OF THE MILK. SHE PURCHASED NEW PARTS IN AN ATTEMPT TO RESOLVE THE ISSUE, BUT IT DID NOT HELP. SHE FURTHER ALLEGED THAT SHE HAD MASTITIS, FOR WHICH SHE WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 8897412 ↗
• InjuryJun 27, 2019Display or Visual Feedback Problem; Noise, Audible

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER SONATA BREAST PUMP IS DISPLAYING A CALL MESSAGE AND IS EXTREMELY LOUD. THE CUSTOMER FURTHER ALLEGED THAT SHE HAS MASTITIS, FOR WHICH SHE IS TAKING AN ANTIBIOTIC.

  Patient problems: Unspecified Infection

  MAUDE report 8739530 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS UNABLE TO EMPTY HER BREASTS WITH HER SONATA BREAST PUMP AND FURTHER ALLEGED THAT SHE HAD MASTITIS ON TWO OCCASIONS. SHE INDICATED THAT SHE WAS NOT CERTAIN IF SHE USED THE PUMP PRIOR TO, OR AFTER, HAVING MASTITIS.

  Patient problems: Unspecified Infection

  MAUDE report 8481986 ↗
• InjuryMar 22, 2019Decrease in Suction

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER SONATA BREAST PUMP HAD LOW SUCTION AND SHE DEVELOPED CLOGGED DUCTS. THE CUSTOMER ADDITIONALLY ALLEGED THAT SHE HAD THRUSH FOR WHICH SHE WAS PRESCRIBED FLUCONAZOLE.

  Patient problems: Fungal Infection; Inflammation

  MAUDE report 8443284 ↗
• InjuryMar 13, 2019Gas/Air Leak; Suction Failure

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC VIA EMAIL THAT EVERY TIME SHE USES HER SONATA BREAST PUMP, IT SHOWED AIR LEAKAGE WHICH ALTERNATED BACK AND FORTH, AND IT WOULD NOT PROPERLY PUMP OR SUCTION. SHE ADDITIONALLY ALLEGED THAT SHE CHARGED IT, TOOK IT WITH HER TO PUMP LATER AND IT DIED AFTER FIVE MINUTES. SHE INDICATED THAT SHE CONTINUOUSLY TAKES IT ALL APART AND SETS IT UP AGAIN. ADDITIONALLY, THE MEMBRANES RIPPED WHEN SHE WAS WASHING THEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8418017 ↗
• InjuryFeb 20, 2019Premature Discharge of Battery

  ON (B)(6) 2019, THE CUSTOMER EMAILED MEDELA LLC ALLEGING THAT THE BATTERY ON HER SONATA BREAST PUMP DISCHARGES IMMEDIATELY AFTER UNPLUGGING FROM MAINS POWER, EVEN WHEN IT SHOWS A FULL CHARGE. SHE ADDITIONALLY ALLEGED THAT SHE HAD MASTITIS.

  Patient problems: Unspecified Infection

  MAUDE report 8354786 ↗
• InjuryFeb 18, 2019Decrease in Suction

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE SUCTION ON HER SONATA BREAST PUMP HAD BEEN LOW FOR TWO MONTHS AND IT WAS DISPLAYING AN AIR LEAK ICON. SHE ADDITIONALLY ALLEGED THAT SHE HAD ALWAYS USED THE PUMP AT THE HIGHEST SETTING AND WAS EXPERIENCING PAIN FROM NOT BEING ABLE TO PUMP DUE TO THE LOW SUCTION.

  Patient problems: Pain

  MAUDE report 8348161 ↗
• InjuryJan 24, 2019Decrease in Suction

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER SONATA BREAST PUMP HAD LOW SUCTION EVEN AT THE MAXIMUM VACUUM SETTING AND SHE WAS EXPERIENCING PAIN UNDER HER ARM. SHE ADDITIONALLY ALLEGED THAT SHE HAD THRUSH, FOR WHICH SHE HAD BEEN PRESCRIBED ANTIFUNGAL MEDICATION.

  Patient problems: No Code Available; Pain

  MAUDE report 8274410 ↗
• InjuryDec 19, 2018Premature Discharge of Battery

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE BATTERY FOR HER THIRD SONATA BREAST PUMP WAS STARTING TO DRAIN PREMATURELY AND THE PUMP WOULD NOT WORK PLUGGED IN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8178271 ↗
• InjuryDec 3, 2018Collapse

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA (B)(4) THAT HER SONATA BREAST PUMP WAS NOT TURNING ON BECAUSE THE POWER BUTTON HAD COLLAPSED INTO THE PUMP. SHE FURTHER ALLEGED THAT SHE HAD MASTITIS AND HAD SEEN A DOCTOR WHO PRESCRIBED HER A SECOND ROUND OF ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 8124053 ↗
• InjuryAug 17, 2018Decrease in Suction; Unable to Obtain Readings; Gas/Air Leak; Noise, Audible

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA (B)(4) THAT HER SONATA BREAST PUMP HAD LOW SUCTION WITH AN AIR LEAK ALERT, HAD A LOUD NOISE COMING FROM THE HOUSING, AND THE DISPLAY WAS DIFFICULT TO READ.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7792728 ↗
• InjuryApr 13, 2018Break; Failure to Align

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA (B)(4) THAT WHEN SHE TOOK HER SONATA BREAST PUMP OUT OF THE BOX, THE HOUSING WAS MISALIGNED AND WHEN SHE PLUGGED THE TUBING IN, THE HOUSING CAME APART AND BROKE THE TUBING. SHE FURTHER ALLEGED THAT BOTH SHE AND HER BABY SLEPT THROUGH THE NIGHT, SHE GOT MASTITIS IN THE MORNING AND WAS NOT ABLE TO USE THE PUMP BECAUSE OF THE BROKEN TUBING AND MISALIGNED HOUSING. SHE SAW HER DOCTOR WHO PRESCRIBED HER AN ANTIBIOTIC FOR THE MASTITIS, WHICH IS ALMOST RESOLVED.

  Patient problems: Inflammation

  MAUDE report 7428273 ↗
• InjuryJan 12, 2018Decrease in Suction; Kinked

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WHEN USING HER SONATA BREAST PUMP AND SHE FOUND A KINK IN THE TUBING, WHICH MUST BE ADJUSTED TO GET SUCTION. THE CUSTOMER INDICATED THAT SHE IS A DOCTOR AND SELF-DIAGNOSED MASTITIS, FOR WHICH SHE WAS TAKING AN ANTIBIOTIC.

  Patient problems: Bacterial Infection

  MAUDE report 7186173 ↗
• InjuryAug 25, 2017Suction Problem

  ON (B)(6)2017, THE CUSTOMER ALLEGED THAT SHE HAD LOW SUCTION WITH HER SONATA BREAST PUMP AND THAT THE BATTERY WAS NOT HOLDING A CHARGE. SHE STATED THAT WHEN BREASTFEEDING SHE HAD A LOT OF PAIN BECAUSE HER TWINS DID NOT LATCH ON PROPERLY, SO SHE STARTED USING THE SONATA INSTEAD AND EXPERIENCED SOME PAIN, BUT IT WAS NOT AS BAD AS WHEN SHE BREASTFED. SHE WAS GIVEN SOME CREAM BUT NO MEDICATION. SHE HAS SCAR TISSUE AND IT IS PAINFUL AS WELL. THE CUSTOMER ALLEGED THAT SHE DID SEE A DOCTOR AND HE TOLD HER SHE COULD STOP USING THE CREAM SINCE SHE WAS HEALED.

  Patient problems: Pain; Scar Tissue

  MAUDE report 6822476 ↗
• InjuryMay 17, 2017Suction Problem; Noise, Audible

  ON (B)(6) 2017, THE CUSTOMER ALLEGED TO CUSTOMER SERVICE THAT HER SONATA BREAST PUMP WAS LOUDER "THAN IT WAS BEFORE" AND SHE HAD TO TURN IT UP TO A LEVEL 10 FOR SUCTION. SHE WAS DIAGNOSED LAST WEEK WITH MASTITIS WHICH WAS TREATED WITH PENICILLIN, BUT SHE IS FINE NOW.

  Patient problems: Inflammation

  MAUDE report 6573474 ↗