Pump In Style Advanced PNSA Tote (REF 101036449;101036450)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00020451364490), received between Aug 27, 2019 and Mar 17, 2021 — classified as 8 injuries.

The most frequently reported specific device problem is “Decrease in Suction” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2021Decrease in Suction

  ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE HAS AN INFECTION AND WAS ADMITTED INTO THE HOSPITAL DUE TO HER PUMP IN STYLE BREAST PUMP HAVING LOW SUCTION.

  Patient problems: Unspecified Infection

  MAUDE report 11506554 ↗
• InjuryFeb 5, 2021Increase in Suction

  ON (B)(6) 2020 THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD HIGH SUCTION, WHICH LED TO HER GETTING MASTITIS AND BEING PRESCRIBED A HOSPITAL GRADE PUMP.

  Patient problems: Unspecified Infection

  MAUDE report 11287334 ↗
• InjuryAug 26, 2020Suction Problem

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD LOW SUCTION WHEN DOUBLE PUMPING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10453108 ↗
• InjuryMay 8, 2020Decrease in Suction

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD LOW SUCTION CAUSING BLOCKED MILK DUCTS. SHE ADDITIONALLY ALLEGED THAT SHE HAD MASTITIS OVER THREE MONTHS AGO, FOR WHICH SHE WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 10038922 ↗
• InjuryMar 27, 2020Failure to Power Up

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WOULD NOT POWER ON. SHE ADDITIONALLY ALLEGED THAT SHE HAD MASTITIS, FOR WHICH SOUGHT MEDICAL TREATMENT.

  Patient problems: Unspecified Infection

  MAUDE report 9887853 ↗
• InjuryFeb 17, 2020Decrease in Suction; Noise, Audible

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD BEEN MAKING A CLICKING SOUND AND HAD LOW SUCTION. SHE ADDITIONALLY ALLEGED THAT SHE HAD A CLOGGED DUCT THAT DEVELOPED INTO MASTITIS, BUT THIS OCCURRED BEFORE SHE STARTED HAVING ISSUES WITH HER BREAST PUMP.

  Patient problems: Inflammation

  MAUDE report 9717299 ↗
• InjuryJan 24, 2020Decrease in Suction

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD LOW SUCTION. SHE ADDITIONALLY ALLEGED THAT SHE DEVELOPED MASTITIS FOUR (4) TIMES, HAD TAKEN ANTIBIOTICS FOR THE FIRST TWO (2) OCCURRENCES, BUT FOR THE LAST TWO OCCURRENCES SHE DID NOT GO TO THE DOCTOR AND THE MASTITIS WENT AWAY ON ITS OWN.

  Patient problems: Unspecified Infection

  MAUDE report 9626838 ↗
• InjuryAug 27, 2019Increase in Suction

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP RANDOMLY CHANGES TO HIGH SUCTION WHILE PUMPING, WHICH CAUSED HER NIPPLES TO BLEED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8934582 ↗