Pump In Style 101041265Recalls & reported problems
Medela LLC · Powered Double Breast Pump · Class 2
All models of Pump In Style (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00020451412658), received between Jun 25, 2021 and Sep 4, 2025 — classified as 20 injuries.
The most frequently reported specific device problem is “Decrease in Suction” (8 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.
Reports received per month
Most reported problems
Device problems
- Decrease in Suction8
- Power Problem4
- Suction Problem4
- Failure to Power Up2
- Energy Output Problem1
- Pumping Stopped1
- Therapeutic or Diagnostic Output Failure1
- Unexpected Shutdown1
Patient problems
- Unspecified Infection9
- Inflammation7
- Insufficient Information2
- Bacterial Infection1
- Blister1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2025Pumping Stopped; Pumping Stopped
ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD SHUT OFF. ADDITIONALLY, THE CUSTOMER REPORTED THAT SHE HAD DEVELOPED MASTITIS SHE THEN WENT TO THE DOCTOR'S OFFICE AND RECEIVED MEDICATION.
Patient problems: Inflammation
MAUDE report 22962820 ↗InjuryJul 25, 2025Suction Problem; Suction Problem
ON (B)(6) 2025, THE CUSTOMER ALLEGED THAT THAT HER PUMP IN STYLE HAD LOW SUCTION. ADDITIONALLY, SHE ALLEGED THAT SHE DEVELOPED MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC.
Patient problems: Inflammation
MAUDE report 22610963 ↗InjuryMay 13, 2025Power Problem; Power Problem
ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD NO POWER. SHE ADDITIONALLY ALLEGED, SHE HAD DEVELOPED MASTITIS TWICE AND WAS PRESCRIBED ANTIBIOTICS BY HER DOCTOR.
Patient problems: Inflammation
MAUDE report 22010149 ↗InjuryApr 24, 2025Suction Problem; Suction Problem
ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD LOW SUCTION, AND SHE DEVELOPED MASTITIS.
Patient problems: Inflammation
MAUDE report 21898068 ↗InjuryAug 24, 2023Power Problem; Power Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WAS NOT POWERING ON. SHE ADDITIONALLY ALLEGED SHE HAD MASTITIS, WENT TO THE DOCTOR AND WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Inflammation
MAUDE report 17614956 ↗InjuryAug 24, 2023Power Problem; Power Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WAS NOT POWERING ON. SHE ADDITIONALLY ALLEGED SHE HAD MASTITIS, WENT TO THE DOCTOR AND WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Inflammation
MAUDE report 17612991 ↗InjuryApr 17, 2023Power Problem; Power Problem
ON (B)(6) 2023, THE CUSTOMER CONTACTED MEDELA LLC AND ALLEGED SHE HAS MASTITIS FROM HER TWO PUMP IN STYLE MAX FLOW BREAST PUMPS HAVING POWER ISSUES. SHE IS TAKING ANTIBIOTICS AND IS UNHAPPY WITH HER PUMP.
Patient problems: Inflammation
MAUDE report 16751588 ↗InjuryJan 18, 2023Decrease in Suction
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC WHILE USING HER PUMP IN STYLE MAXFLOW PUMP SHE WAS EXPERIENCING LOW TO NO SUCTION. THE CUSTOMER STATED BEFORE CALLING SHE HAD PURCHASED NEW PUMPING PARTS AND IT DID NOT IMPROVE THE SUCTION. THE CUSTOMER ALSO ALLEGED SHE HAD DEVELOPED MASTITIS AND WAS PRESCRIBED ANTIBIOTICS TO TREAT IT.
Patient problems: Unspecified Infection
MAUDE report 16195951 ↗InjuryDec 15, 2022Decrease in Suction
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC WHILE USING PUMP IN STYLE MAXFLOW PUMP IT HAD NO SUCTION. MOM IS USING HER OLDER PUMP CURRENTLY TO EXPRESS HER MILK. THE CUSTOMER ALSO ALLEGED SHE DEVELOPED MASTITIS FROM HER PUMP IN STYLE MAXFLOW SINCE IT WAS NOT EMPTYING HER BREAST MILK. SHE WAS PRESCRIBED MEDICATION TO TREAT THE MASTITIS.
Patient problems: Unspecified Infection
MAUDE report 15988851 ↗InjuryNov 16, 2022Decrease in Suction; Energy Output Problem
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC WHILE USING HER PUMP IN STYLE MAXFLOW SHE WAS HAVING ISSUES WITH THE PUMP NOT HAVING RELIABLE SUCTION. SHE ALSO STATED SHE HAD TO INCREASE THE PUMPS SUCTION SO HIGH TO GET PROPER MILK EXPRESSION THAT IT CAUSED BLISTERS ON HER NIPPLES. SHE ALSO THOUGHT THAT THE BREAST SHIELDS, CONNECTORS AND MEMBRANES WERE CAUSING PRODUCTIVITY ISSUES. SHE HAD TO RELY ON HER OLDER PUMP IN STYLE ADVANCED BREAST PUMP TO GET HER THROUGH PUMPING, IT IS WORKING WELL FOR HER.
Patient problems: Blister
MAUDE report 15806763 ↗InjurySep 20, 2022Decrease in Suction
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE MAX FLOW BREAST PUMP. THE CUSTOMER ADDITIONALLY REPORTED SHE HAD MASTITIS AND JUST FINISHED TAKING ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 15454877 ↗InjuryJul 26, 2022Decrease in Suction
ON 06/27/2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAXFLOW HAS LOW SUCTION AND SHE DEVELOPED MASTITIS.
Patient problems: Bacterial Infection
MAUDE report 15102326 ↗InjuryJun 9, 2022Decrease in Suction
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW HAS LOW SUCTION AND SHE HAS MASTITIS.
Patient problems: Unspecified Infection
MAUDE report 14644704 ↗InjuryMay 10, 2022Suction Problem
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT IT WAS TAKING HER A LONG TIME EMPTY HERSELF DUE TO THE SUCTION ON HER PUMP IN STYLE MAX FLOW AND IS ENGORGED. ADDITIONALLY, SHE ALLEGED THAT SHE WENT TO (B)(6) OVER THE WEEKEND DUE TO MASTITIS AND WAS PLACED ON AN ANTIBIOTIC.
Patient problems: Unspecified Infection
MAUDE report 14345621 ↗InjuryMay 4, 2022Failure to Power Up
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW BREAST PUMP WORKS WITH THE POWER CORD BUT DOESN'T POWER ON WITH THE BATTERY PACK. ON 04/01/2022, SHE CONTACTED US BACK. SHE HAS TRIED NEW BATTERIES AND STILL IS HAVING ISSUES. ON 04/15/2022, SHE CONTACTED US AGAIN AND IS STILL HAVING BATTERY PACK ISSUES AND NOW HAS MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC.
Patient problems: Unspecified Infection
MAUDE report 14280561 ↗InjuryApr 12, 2022Therapeutic or Diagnostic Output Failure
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS HAVING ISSUES WITH HER PUMP IN STYLE MAX FLOW NOT FULLY EMPTYING HER BREAST.
Patient problems: Insufficient Information
MAUDE report 14088118 ↗InjuryFeb 11, 2022Decrease in Suction
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW HAS LOW SUCTION AND SHE DEVELOPED MASTITIS FOR WHICH SHE WAS PRESCRIBED AN ANTIBIOTIC.
Patient problems: Unspecified Infection
MAUDE report 13514818 ↗InjuryOct 22, 2021Decrease in Suction
ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW BREAST PUMP HAD LOW SUCTION WHICH LED TO MASTITIS.
Patient problems: Unspecified Infection
MAUDE report 12681478 ↗InjurySep 2, 2021Suction Problem; Unexpected Shutdown
ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW BREAST PUMP HAD LOW SUCTION AND WAS RANDOMLY SHUTTING OFF WHILE IN USE. SHE CALLED BACK LATER THE SAME DAY AND STATED THE LOW SUCTION STARTED TODAY. SHE INDICATED SHE HAD MASTITIS AND WAS HOSPITALIZED DUE TO IT. HER MASTITIS HAS BEEN RESOLVED.
Patient problems: Unspecified Infection
MAUDE report 12413330 ↗InjuryJun 25, 2021Failure to Power Up
ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW BREAST PUMP WOULD NOT POWER ON SHE HAD TRIED THE POWER CORD AND BATTERY PACK.
Patient problems: Insufficient Information
MAUDE report 12070270 ↗
Other Pump, Breast, Powered devices
- Pump In Style 101041360Medela LLC · Pump, Breast, Powered127 reports
- Pump In Style Advanced PNSA Starter PumpMedela LLC · Pump, Breast, Powered82 reports
- Pump In Style 101041361Medela LLC · Pump, Breast, Powered41 reports
- Freestyle Hands-free 101044164Medela AG · Pump, Breast, Powered26 reports
- Pump in Style Advanced PNSA Starter PumpMedela LLC · Pump, Breast, Powered23 reports
- Sonata Breastpump Sonata DeluxeMedela LLC · Pump, Breast, Powered22 reports
- Pump Kit, Gen 3 (2S), 2PK, White, 24mm PDW48Willow Innovations, Inc. · Pump, Breast, Powered14 reports
- Freestyle Freestyle ToteMedela AG · Pump, Breast, Powered12 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page