Pump In Style Advanced Advanced Personal Double Breast Pump (REF 101038299)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00020451382999), received between Feb 4, 2020 and Apr 1, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Component Missing” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2020Decrease in Suction

  ON (B)(6) 2020, A MOTHER ALLEGED TO MEDELA LLC THAT HER DAUGHTERS' PUMP IN STYLE BREAST PUMP HAD LOW SUCTION. SHE ADDITIONALLY ALLEGED THAT HER DAUGHTER HAD MASTITIS FOURS TIMES AND WAS CURRENTLY ON ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 9910625 ↗
• InjuryFeb 4, 2020Component Missing; Suction Failure

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC VIA EMAIL THAT SHE WAS UNHAPPY WITH HER HARMONY MANUAL BREAST PUMP, AS SHE HAD NOTICED A LACK OF SUCTION AND SHE WAS ENGORGED. SHE INDICATED THAT SHE FOUND THAT THE O-RING WAS MISSING AFTER TROUBLESHOOTING ON HER OWN. SHE ADDITIONALLY ALLEGED THAT SHE HAD BEEN DEALING WITH BLOCKED DUCTS AND RECURRENT MASTITIS, FOR WHICH SHE WAS ON ANTIBIOTICS FOR ONE MONTH, DUE TO OVERSUPPLY.

  Patient problems: Swelling; Unspecified Infection

  MAUDE report 9664406 ↗

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