Freestyle Breastpump, Deluxe Set 67060Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00020451670607), received between Aug 7, 2017 and Jul 15, 2019 — classified as 6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2019Suction Problem

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE BREAST PUMP STOPPED SUCTIONING AFTER FIVE MINUTES AND SHE WAS WORRIED ABOUT GETTING A 3RD BOUT OF MASTITIS.

  Patient problems: Unspecified Infection

  MAUDE report 8790178 ↗
• InjuryMar 13, 2019Decrease in Suction

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC VIA EMAIL THAT SHE PURCHASED A FREESTYLE BREAST PUMP (PARTLY COVERED BY INSURANCE) BACK IN (B)(6) AND HAD BEEN USING THE PUMP MULTIPLE TIMES DAILY SINCE (B)(6) AND FEELS THAT THE VACUUM SUCTION HAS LOST A LOT OF POWER RECENTLY. SHE FURTHER ALLEGED THAT SHE WAS NOT EXPRESSING NEARLY AS MUCH AS SHE DOES WHEN USING AN ALTERNATE NEW PUMP IN STYLE BREAST PUMP AND WAS EXPERIENCING A LOT OF BLOCKED DUCTS WHEN USING THE FREESTYLE PUMP.

  Patient problems: Obstruction/Occlusion

  MAUDE report 8416660 ↗
• InjuryJan 23, 2019Decrease in Suction

  ON (B)(6) 2019, THE CUSTOMER REPORTED TO MEDELA LLC THAT THE SUCTION ON HER FREESTYLE BREAST PUMP WAS LOW AND SHE KEEPS DEVELOPING MASTITIS, FOR WHICH SHE WAS PRESCRIBED AN ANTIBIOTIC. SHE ADDITIONALLY ALLEGED THAT SHE HAD THRUSH AND HER DOCTOR ADVISED HER TO GET A NEW PUMP.

  Patient problems: Fungal Infection; Inflammation

  MAUDE report 8270479 ↗
• InjuryJan 9, 2019No Device Output; Component Missing

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE BREAST PUMP WAS NOT EMPTYING HER BREASTS AND HER TWO HARMONY MANUAL PUMPS WERE MISSING O-RINGS. SHE ADDITIONALLY ALLEGED THAT SHE DEVELOPED MASTITIS TWICE, HAD CLOGGED DUCTS, AND HAD SEEN A DOCTOR WHO PRESCRIBED ORAL AND CREAM ANTIBIOTICS. SHE ALSO STATED THAT A LACTATION CONSULTANT RECOMMENDED THAT SHE USE A HOSPITAL-GRADE SYMPHONY BREAST PUMP.

  Patient problems: Unspecified Infection

  MAUDE report 8231173 ↗
• InjuryMay 31, 2018Decrease in Suction

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA (B)(4) THAT SHE WAS EXPERIENCING LOW SUCTION WHEN DOUBLE PUMPING WITH HER FREESTYLE BREAST PUMP. DURING TROUBLESHOOTING WITH CUSTOMER SERVICE, THE CUSTOMER INDICATED THAT OF THE TWO SETS OF SPARE PARTS SHE HAS, SHE IS ABLE TO GET SUCTION WITH ONE SET. DURING THE TROUBLESHOOTING, THE CUSTOMER REASSEMBLED THE PARTS, TESTED THE PUMP AND INDICATED THAT THE SUCTION WAS WORKING. REPLACEMENTS PARTS WERE SENT TO THE CUSTOMER. ON (B)(6) 2018, THE CUSTOMER CALLED BACK AND ALLEGED TO MEDELA (B)(4) THAT SHE WAS EXPERIENCING LOW SUCTION AGAIN WHEN DOUBLE PUMPING WITH HER FREESTYLE BREAST PUMP. SHE ALLEGED THAT ONE SIDE DOES NOT ALWAYS HAVE SUCTION WHEN SHE DOUBLE PUMPS, BUT THERE IS NO SUCTION ISSUE WHEN SHE SINGLE PUMPS. THE CUSTOMER ALLEGED THAT SHE WAS ENGORGED, BUT WAS ABLE TO RELIEVE THE ENGORGEMENT BY HERSELF.

  Patient problems: Inflammation; Swelling

  MAUDE report 7556911 ↗
• InjuryAug 7, 2017Decrease in Suction

  ON (B)(6) 2017, THE CUSTOMER ALLEGED THAT HER FREESTYLE BREAST PUMP WAS PRODUCING LOW SUCTION. SHE REFUSED TO CONDUCT TROUBLESHOOTING. SHE WAS INSTRUCTED TO RETURN THE PUMP BEFORE A REPLACEMENT WOULD BE SENT TO HER. ON (B)(6) 2017, THE CUSTOMER MADE A SECOND CONTACT, ALLEGING THAT SHE WAS USING THE 27 MM BREAST SHIELDS WITH THE FREESTYLE PUMP AND THEY CAUSED A RASH ON HER BREASTS, FOR WHICH SHE SAW A DOCTOR AND WAS GIVEN A CREAM. ON (B)(6) 2017, THE CUSTOMER MADE A THIRD CONTACT, INDICATING THAT SHE SENT HER FREESTYLE PUMP BACK. HOWEVER, TRACKING INFORMATION DOES NOT SUBSTANTIATE THAT CLAIM. SHE INDICATED THAT THE DOCTOR GAVE HER AN ANTIBIOTIC CREAM WHICH SHE USED FOR 2 WEEKS AND SHE CAN USE THE PUMP AGAIN. SHE INQUIRED ABOUT A REPLACEMENT PUMP AND WAS AGAIN INSTRUCTED TO RETURN THE ORIGINAL PUMP BEFORE A REPLACEMENT WOULD BE SENT. ON (B)(6) 2017, THE CUSTOMER MADE A FOURTH CONTACT AND WAS ESCALATED TO A LEAD. THE CUSTOMER ONCE AGAIN STATED THAT SHE RETURNED THE PUMP; HOWEVER, TRACKING INFORMATION DOES NOT SUBSTANTIATE THAT CLAIM.

  Patient problems: Rash

  MAUDE report 6770562 ↗