Pump In Style Advanced PNSA Tote (REF 57063)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00020451570631), received between Apr 26, 2017 and Sep 27, 2019 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Decrease in Suction” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K031614); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2019Suction Problem

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD LOW SUCTION. THE CUSTOMER FURTHER ALLEGED THAT SHE WAS DIAGNOSED WITH MASTITIS, FOR WHICH SHE STARTED TREATMENT.

  Patient problems: Unspecified Infection

  MAUDE report 9130157 ↗
• InjuryJul 12, 2019Decrease in Suction

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE BREAST PUMP. SHE ADDITIONALLY ALLEGED THAT SHE HAD MASTITIS DUE TO THE LOW SUCTION AND SHE HAD SEEN HER HEALTHCARE PROVIDER, WHO PRESCRIBED HER ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 8784421 ↗
• InjuryMay 7, 2019Decrease in Suction

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD LOW SUCTION ON THE LEFT SIDE. SHE ADDITIONALLY ALLEGED THAT SHE HAD MASTITIS AND WAS PRESCRIBED ANTIBIOTICS, BUT DID NOT THINK THE MASTITIS WAS DUE TO THE PUMP.

  Patient problems: Unspecified Infection

  MAUDE report 8585781 ↗
• InjuryApr 12, 2019Decrease in Suction

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE HAD LOW SUCTION WITH HER PUMP IN STYLE BREAST PUMP AND THAT SHE HAD AN INFECTION THE PREVIOUS MONTH. SHE ADDITIONALLY ALLEGED THAT SHE WAS TREATED BY A MEDICAL PROFESSIONAL WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 8508746 ↗
• MalfunctionMar 13, 2019Break; Fumes or Vapors

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE POWER SUPPLY FOR HER PUMP IN STYLE BREAST PUMP HAD AN ELECTRICAL SMOKE ODOR AND THE HOUSING HAD BROKEN APART. SHE ADDITIONALLY ALLEGED THAT THE POWER SUPPLY WAS HOT AND BURNED HER FINGER WHEN SHE TOUCHED IT.

  Patient problems: Burn, Thermal

  MAUDE report 8418013 ↗
• InjuryFeb 21, 2019Decrease in Suction

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC VIA EMAIL THAT HER PUMP IN STYLE BREAST PUMP WAS "BROKEN" AND NO LONGER EMPTIES HER BREASTS; EVEN WHEN ON MAXIMUM VACUUM SETTING, IT WILL NOT SUCTION HARD ENOUGH TO EVEN "GRAB HER SKIN." SHE FURTHER ALLEGED THAT SHE WAS GETTING CLOGGED DUCTS AND HER SUPPLY WAS DECREASING BECAUSE SHE CANNOT GET THE PUMP TO FUNCTION AS IT USED TO. SHE INDICATED THAT SHE HAS BOUGHT ALL NEW PARTS MULTIPLE TIMES. ON (B)(6) 2019, THE CUSTOMER PHONED MEDELA LLC, CONFIRMING LOW SUCTION WITH BOTH THE BATTERY PACK AND THE POWER ADAPTER AND FURTHER ALLEGING THAT SHE DEVELOPED MASTITIS WHILE PUMPING AND BREASTFEEDING. HER DOCTOR ADVISED HER THAT HER BREASTS WERE NOT EMPTYING AND SHE SHOULD PUMP MORE OFTEN AND THIS IS WHEN SHE DEVELOPED CLOGGED DUCTS. SHE WAS PUT ON AN ANTIBIOTIC A MONTH PREVIOUSLY FOR 10 DAYS. SHE IS BETTER, BUT NOT BEING ABLE TO EMPTY HER BREASTS IS NOT HELPING.

  Patient problems: Unspecified Infection

  MAUDE report 8357263 ↗
• InjuryFeb 20, 2019Failure to Power Up

  ON (B)(6) 2019, THE CUSTOMER EMAILED MEDELA LLC ALLEGING THAT THE BATTERY PACK FOR HER PUMP IN STYLE BREAST PUMP WAS NOT POWERING THE PUMP, DESPITE THE FACT THAT SHE USED BRAND NEW BATTERIES. SHE FURTHER ALLEGED THAT IT CAUSED HER TO BECOME ENGORGED AT WORK.

  Patient problems: No Code Available

  MAUDE report 8354831 ↗
• InjuryJan 14, 2019Patient-Device Incompatibility

  ON (B)(6) 2018, THE CUSTOMER REPORTED TO MEDELA LLC THAT EVERY TIME SHE PUMPS WITH HER PUMP IN STYLE BREAST PUMP, SHE BLEEDS AND IT IS GETTING MORE AND MORE PAINFUL TO PUMP. SHE ADDITIONALLY ALLEGED THAT THOUGH SHE HAS NOT SOUGHT MEDICAL ATTENTION AT THIS TIME, SHE DEVELOPED MASTITIS THE THIRD MONTH INTO USING THE PUMP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain

  MAUDE report 8244440 ↗
• InjurySep 28, 2017Decrease in Suction

  ON (B)(6) 2017, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE BREAST PUMP. SHE REPORTED THAT SHE HAD A FEW CLOGGED DUCTS IN THE PAST FOR WHICH SHE WAS PRESCRIBED ANTIBIOTICS. SHE INDICATED THAT SHE DOES NOT HAVE CLOGGED DUCTS PRESENTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6901633 ↗
• InjurySep 22, 2017Decrease in Suction

  ON (B)(6) 2017, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE ADVANCED BREAST PUMP. SHE REPORTED THAT SHE HAD BEEN TO THE DOCTOR FOUR TIMES AND WAS DIAGNOSED WITH MASTITIS TWICE, FOR WHICH SHE WAS PRESCRIBED ANTIBIOTICS. THE CUSTOMER ALSO MENTIONED THAT SHE GETS CLOGGED DUCTS TWICE A WEEK.

  Patient problems: Inflammation; Swelling; Unspecified Infection

  MAUDE report 6887888 ↗
• InjuryApr 26, 2017Suction Problem

  ON (B)(6) 2017, THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT SUCTION ON HER PUMP IN STYLE ADVANCED BREAST PUMP WAS LOW. SHE ALSO STATED THAT SHE HAD MASTITIS.

  Patient problems: Unspecified Infection

  MAUDE report 6523038 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031614. One submission often covers many models, so check the product and lot details in each record.

• Z-1224-2011 · Jan 10, 2011 · Terminated
  Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Dri