Pump In Style Advanced Pump In Style Advance Backpack (REF 101036453;101036448)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00020451364537), received between Mar 9, 2020 and May 13, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Decrease in Suction” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WAS CAUSING PAIN AND SHE HAD SORES AT THE BASE OF HER NIPPLES. SHE ADDITIONALLY ALLEGED THAT SHE HAD ALREADY TRIED SMALLER BREAST SHIELDS AND HER DOCTOR HAD CONFIRMED THE PAIN WAS CAUSED BY THE PUMP AND NOT THE BABY.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 11821405 ↗
• InjuryMar 11, 2021Decrease in Suction

  ON (B)(6) 2021 THE CUSTOMER ALLEGED VIA EMAIL TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD VERY LITTLE SUCTION EVEN AFTER CHECKING ALL HER PUMP PARTS AND DIAPHRAGM FOR WEAR. THE CUSTOMER ALSO ALLEGED THAT SHE BOUGHT REPLACEMENT PARTS WHICH DID NOT HELP AND SHE DEVELOPED MASTITIS 3 TIMES WITHIN A MONTH.

  Patient problems: Unspecified Infection

  MAUDE report 11465680 ↗
• InjuryOct 14, 2020Decrease in Suction

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD LOW SUCTION AND HER BREASTS ARE ENGORGED. THE CUSTOMER ADDITIONALLY ALLEGED THAT HER NIPPLES ARE CRACKED FROM HAVING TO TURN THE SUCTION ON THE PUMP HIGHER AND SHE HAD MASTITIS WHEN SHE STARTED USING THIS PUMP. SHE FEELS SHE IS HEADING THAT WAY AGAIN IN BOTH BREASTS.

  Patient problems: Inflammation

  MAUDE report 10678510 ↗
• InjuryJun 1, 2020Suction Problem

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA (B)(6) THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE BREAST PUMP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10105841 ↗
• InjuryMay 27, 2020Break

  ON (B)(6) 2020, A CUSTOMER ALLEGED TO MEDELA LLC THAT THE TUBING PORTS ON HIS WIFE'S PUMP IN STYLE FACEPLATE WERE BROKEN. HE ADDITIONALLY ALLEGED THAT HIS WIFE WAS STRUGGLING WITH MASTITIS AND WAS DESPERATE TO GET A NEW FACEPLATE.

  Patient problems: Inflammation

  MAUDE report 10091815 ↗
• InjuryMar 18, 2020Decrease in Suction

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD LOW SUCTION, EVEN ON THE HIGHEST VACUUM SETTING. SHE ADDITIONALLY ALLEGED THAT SHE HAD SEEN A DOCTOR AND WAS PRESCRIBED AN ANTIBIOTIC.

  Patient problems: Unspecified Infection

  MAUDE report 9849730 ↗
• InjuryMar 9, 2020Suction Failure

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WORKS NORMALLY IN THE FIRST PHASE, HOWEVER, WHEN SWITCHING INTO THE SECOND PHASE, IT LOSES ALL THE SUCTION. SHE ADDITIONALLY ALLEGED THAT SHE HAS MASTITIS, FOR WHICH SHE HAS RECEIVED ANTIBIOTICS FROM HER DOCTOR.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 9806690 ↗