Freestyle Freestyle ToteRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00020451330921), received between Feb 13, 2020 and May 7, 2021 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Decrease in Suction” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2021Decrease in Suction

  ON (B)(6) 2021 THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE BREAST PUMP HAD LOW SUCTION AND SHE HAD MASTITIS, FOR WHICH SHE WAS PRESCRIBED AN ANTIBIOTIC.

  Patient problems: Unspecified Infection

  MAUDE report 11793933 ↗
• InjuryJul 20, 2020Defective Component

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC VIA EMAIL THAT SHE HAD ANOTHER INSTANCE OF MASTITIS WHEN USING THE REPLACEMENT FREESTYLE BREAST PUMP SHE RECEIVED AS A RESULT OF THE INCIDENT REPORTED IN MEDWATCH 1419937-2020-00057. SHE ALLEGED THAT HER RIGHT BREAST WAS PRODUCING LESS MILK DUE TO THE FAULTY PUMP AND REQUESTED THAT A FREESTYLE FLEX BREAST PUMP BE SENT TO HER, WHICH HER LACTATION SPECIALIST ADVISED.

  Patient problems: Unspecified Infection

  MAUDE report 10298570 ↗
• MalfunctionJun 19, 2020Adverse Event Without Identified Device or Use Problem

  ON 05/12/020, THE CUSTOMER ALLEGED VIA CHAT TO MEDELA LLC THAT THE FREESTYLE PUMP SHE HAD RECEIVED IN (B)(6) WAS NOT EMPTYING HER BREASTS, WHICH HAD CAUSED HER TO GET AN ABSCESS AND SHE HAD TO RENT A HOSPITAL GRADE PUMP FOR THE PREVIOUS TWO MONTHS. SHE ADDITIONALLY ALLEGED SHE HAD TRIED REPLACING THE SPARE PARTS, BUT IT STILL DID NOT RESOLVE THE ISSUE AND SHE WOULD LIKE TO GET A DIFFERENT MEDELA PUMP.

  Patient problems: Abscess

  MAUDE report 10173979 ↗
• InjuryJun 15, 2020Suction Problem

  ON 04/23/2020, THE CUSTOMER ALLEGED TO MEDELA LLC VIA CHAT THAT HER FREESTYLE BREAST PUMP HAD LOW SUCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10153533 ↗
• InjuryJun 11, 2020Increased Pump Speed

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE SPEED ON HER SYMPHONY RENTAL BREAST PUMP GOES FROM LOW TO HIGH ON ITS OWN AND WHEN IT DOES, IT CAUSES PAIN.

  Patient problems: Pain

  MAUDE report 10142508 ↗
• InjuryJun 2, 2020Decrease in Suction

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER FREESTYLE BREAST PUMP, EVEN ON THE MAXIMUM VACUUM SETTING. SHE ADDITIONALLY ALLEGED THAT SHE WAS DEVELOPING MASTITIS, FOR WHICH SHE WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Inflammation

  MAUDE report 10108390 ↗
• InjuryMay 20, 2020Decrease in Suction

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE BREAST PUMP HAD LOW SUCTION AND SHE HAD MASTITIS, FOR WHICH SHE WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Inflammation

  MAUDE report 10074503 ↗
• InjuryMay 1, 2020Fitting Problem

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE HAD LOW MILK EXPRESSION WHILE USING HER MEDELA FREESTYLE BREAST PUMP WITH HER SECOND BABY AND HER BREAST SHIELDS DID NOT FIT CORRECTLY.

  Patient problems: No Code Available

  MAUDE report 10017044 ↗
• InjuryApr 9, 2020Decrease in Suction

  ON (B)(6) 2020, THE CUSTOMER ALLEGED VIA EMAIL TO MEDELA LLC THAT HER FREESTYLE BREAST PUMP WAS LOSING SUCTION DURING EVERY PUMPING SESSION, CAUSING HER TO HAVE TO DISCONNECT AND REATTACH ALL OF THE SPARE PARTS TO REGAIN SUCTION. SHE ADDITIONALLY ALLEGED THAT SHE WAS DISAPPOINTED IN THE PUMP AND FELT THAT IT CONTRIBUTED TO HER RECENT MASTITIS. SHE REQUESTED A RETURN, EXCHANGE, OR TO RECEIVE CONSOLATION SINCE IT WAS AN INCONVENIENCE TO HER AND HER EXCLUSIVELY BOTTLE-FED BABY.

  Patient problems: Unspecified Infection

  MAUDE report 9942732 ↗
• InjuryMar 16, 2020Break

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE TUBING FOR HER FREESTYLE BREAST PUMP HAD A BROKEN ADAPTER AND IT CONTAINED RESIDUE. SHE ADDITIONALLY ALLEGED THAT SHE HAD THRUSH, FOR WHICH SHE HAD BEEN TREATED BY HER DOCTOR.

  Patient problems: Unspecified Infection

  MAUDE report 9835880 ↗
• InjuryMar 5, 2020Decrease in Suction

  ON 02/07/2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE BREAST PUMP HAD LOW SUCTION AND HER NIPPLES WERE BURNING AFTER PUMPING, DUE TO NOT BEING ABLE TO PUMP.

  Patient problems: Burning Sensation

  MAUDE report 9793539 ↗
• InjuryFeb 13, 2020Decrease in Suction

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE BREAST PUMP HAD LOW SUCTION AND SHE HAD TO SELF-EXPRESS AFTER PUMPING. SHE ADDITIONALLY ALLEGED THAT SHE WAS ENGORGED AND HAD BEEN TREATED FOR MASTITIS.

  Patient problems: Unspecified Infection

  MAUDE report 9707453 ↗