Pump In Style Advanced Pump In Style Advance Backpack (REF 57062)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00020451570624), received between May 11, 2017 and Sep 11, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 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 SHE HAD MASTITIS, FOR WHICH SHE WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 8988173 ↗
• InjuryFeb 13, 2019Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE AND HER BABY WERE BEING TREATED FOR THRUSH AND SHE EXPRESSED CONCERN THAT THE FUNGI MAY HAVE BEEN TRANSFERRED TO HER PUMP IN STYLE BREAST PUMP. THE CUSTOMER ALSO ALLEGED THAT BOTH SHE AND HER BABY WERE UNDERGOING TREATMENT WITH ANTI-FUNGAL MEDICATION.

  Patient problems: Fungal Infection

  MAUDE report 8337027 ↗
• InjuryMay 11, 2017Break

  ON (B)(6) 2017, THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE TUBING CONNECTOR FOR HER PUMP IN STYLE ADVANCED BREAST PUMP WAS DAMAGED AND IT AFFECTED THE SUCTION. ON (B)(6) 2017, WHEN RESPONDING TO A REQUEST TO RETURN THE PRODUCT, THE CUSTOMER INDICATED THAT SHE DEVELOPED MASTITIS.

  Patient problems: Unspecified Infection

  MAUDE report 6560118 ↗

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