Pump In Style 101041360Recalls & 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
Quick summary
This Medela Pump In Style breast pump is a powered double breast pump. All 127 reports are injuries, with no deaths; many describe weak or failing suction, and many users allege breast infection such as mastitis, some needing antibiotics. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 127
- Deaths reported
- 0
- Injuries reported
- 127
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 00020451401447), received between Feb 5, 2021 and Apr 8, 2026 — classified as 127 injuries.
The most frequently reported specific device problem is “Decrease in Suction” (44 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 Suction44
- Suction Problem34
- Adverse Event Without Identified Device or Use Problem8
- Suction Failure6
- Break5
- Failure to Power Up5
- Noise, Audible5
- Output Problem5
Patient problems
- Unspecified Infection70
- Inflammation35
- Bacterial Infection11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- Obstruction/Occlusion5
- Pain4
- Insufficient Information2
- Unspecified Reproductive System or Breast Problem2
Recent adverse event reports
The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2026Power Problem
ON (B)(6) 2026, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WOULD TURN OFF WHILE USING IT. ADDITIONALLY, THE CUSTOMER ALLEGED THAT SHE DEVELOPED CLOGGED DUCTS AND MASTITIS.
Patient problems: Inflammation
MAUDE report 24814578 ↗InjuryApr 24, 2025Suction Problem; Suction Problem
ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING SUCTION ISSUES WITH HER PUMP IN STYLE MAX FLOW BREAST PUMP. SHE ADDITIONALLY REPORTED THAT SHE HAD MASTITIS AND WENT TO HER DOCTOR AND WAS PRESCRIBED AN ANTIBIOTIC.
Patient problems: Inflammation
MAUDE report 21904184 ↗InjuryMar 24, 2025Suction Problem; Suction Problem
ON (B)(6) 2025, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAXFLOW BREAST PUMP WAS HAVING LOW SUCTION. ADDITIONALLY, THE CUSTOMER ALLEGED SHE HAD DEVELOPED MASTITIS FROM NOT BEING ABLE TO PUMP HER BREAST MILK. SHE WENT TO THE DOCTOR AND WAS PRESCRIBED ANTIBIOTICS TO TREAT THE MASTITIS.
Patient problems: Inflammation
MAUDE report 21677473 ↗InjuryDec 2, 2024Suction Problem; Suction Problem
ON (B)(6)2024, THE CUSTOMER ALLEGED TO MEDELA LLC VIA EMAIL THAT HER PUMP IN STYLE BREAST PUMP WAS NOT EMPTYING HER AS IT SHOULD AND THAT SHE WAS GETTING MASTITIS.
Patient problems: Inflammation
MAUDE report 20817535 ↗InjurySep 30, 2024Suction Problem; Suction Problem
ON 9/25/2024, THE CUSTOMER ALLEGED VIA EMAILED MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WAS NOISY AND HAD LOW SUCTION. ADDITIONALLY, SHE ALLEGED THAT SHE DEVELOPED MASTITIS AND SEPSIS. SHE ALLEGED THAT SHE WENT TO THE EMERGENCY ROOM AND BOUGHT A REPLACEMENT PUMP.
Patient problems: Inflammation
MAUDE report 20338875 ↗InjuryAug 22, 2024Suction Problem; Suction Problem
ON (B)(6) 2024, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW HAD LOW SUCTION. ADDITIONALLY, SHE ALLEGED THAT SHE DEVELOPED MASTITIS AND WAS HOSPITALIZED FOR THREE DAYS AND RECEIVED PRESCRIPTION MEDICATION.
Patient problems: Inflammation
MAUDE report 20033363 ↗InjuryApr 10, 2024Power Problem; Power Problem
ON 04/05/2024, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WAS NOT TURNING ON AND FELT HOT. SHE ADDITIONALLY ALLEGED THAT SHE CURRENTLY HAS MASTITIS AND IS TAKING ANTIBIOTICS.
Patient problems: Inflammation
MAUDE report 19078195 ↗InjuryMar 13, 2024Suction Problem; Suction Problem
ON 03/04/2024, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING SUCTION ISSUES WITH HER PUMP IN STYLE BREAST PUMP. SHE ADDITIONALLY REPORTED THAT SHE HAD MASTITIS DUE TO THE PUMP NOT WORKING PROPERLY AND HAS TAKEN ANTIBIOTICS.
Patient problems: Inflammation
MAUDE report 18892652 ↗InjuryFeb 28, 2024Power Problem; Power Problem
ON (B)(6) 2024, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAXFLOW IS HAVING POWER AND SUCTION ISSUES. THE CUSTOMER ALSO ALLEGED SHE HAD BEEN DIAGNOSED WITH MASTITIS AND PRESCRIBED MEDICATION TO TREAT IT.
Patient problems: Inflammation
MAUDE report 18796097 ↗InjuryJan 11, 2024Suction Problem; Suction Problem
ON (B)(6) 2024, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW WAS NOT EXPRESSING HER AS OTHER PUMPS AND WOULD POWER OFF. ADDITIONALLY, SHE ALLEGED THAT SHE DEVELOPED MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC.
Patient problems: Inflammation
MAUDE report 18491220 ↗InjuryJan 3, 2024Suction Problem; Suction Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD NO SUCTION. SHE ADDITIONALLY REPORTED THAT SHE WAS IN THE HOSPITAL FOR MASTITIS AND HAS TAKEN 4 DIFFERENT ANTIBIOTICS.
Patient problems: Inflammation
MAUDE report 18435029 ↗InjurySep 6, 2023Suction Problem; Suction Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE DOESN'T EXPRESS WELL WITH THE PUMP IN STYLE MAX FLOW BREAST PUMP. ADDITIONALLY, THE CUSTOMER ALLEGED THAT THE PUMP WAS WORKING AND DOING WHAT IT IS SUPPOSED TO, BUT IT IS NOT EXPRESSING LIKE HER PUMP IN STYLE ADVANCED BREAST PUMP. THE CUSTOMER ALLEGED THAT WHEN IT PULLS IT HAS A DIFFERENT TYPE OF PULL WITH THE VIBRATION AND THE CUSTOMER CANNOT TURN IT UP BECAUSE IT HURTS. THE CUSTOMER ALSO ALLEGED THAT SHE DEVELOPED MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC.
Patient problems: Inflammation
MAUDE report 17689320 ↗InjuryJul 6, 2023Suction Problem; Suction Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS NOT RESPONDING TO THE PUMP IN STYLE MAX FLOW AND IT WAS NOT EMPTYING HER. THE CUSTOMER ALSO ALLEGED THAT SHE HAS BEEN STRUGGLING WITH BACK-TO-BACK MASTITIS.
Patient problems: Inflammation
MAUDE report 17270570 ↗InjuryJul 5, 2023Suction Problem; Suction Problem
ON (B)(6) 2023, THE CUSTOMER'S HUSBAND ALLEGED TO MEDELA LLC THAT HIS WIFE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE MAX FLOW BREAST PUMP AND MOM IS UNABLE TO EXPRESS MILK. SHE IS GETTING ENGORGED AND IS ON AN ANTIBIOTIC. SHE GETS MORE MILK EXPRESSION USING A SYMPHONY BREAST PUMP.
Patient problems: Inflammation
MAUDE report 17258837 ↗InjuryJul 3, 2023Suction Problem; Suction Problem
ON(B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT WHILE USING HER PUMP IN STYLE WITH MAXFLOW PUMP SHE WAS UNABLE TO GET ADEQUATE SUCTION TO EMPTY HER BREASTS OF BREAST MILK. THE CUSTOMER ALSO ALLEGED SHE HAD CLOGGED DUCTS AND MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC.
Patient problems: Inflammation
MAUDE report 17246321 ↗InjuryJun 27, 2023Power Problem; Power Problem
ON 6/20/2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE WITH MAXFLOW PUMP WAS EXPERIENCING POWER ISSUES. THE CUSTOMER ALSO ALLEGED SHE WAS DIAGNOSED WITH MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC ON (B)(6) 2023.
Patient problems: Inflammation
MAUDE report 17208888 ↗InjuryJun 15, 2023Suction Problem; Suction Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW BREAST PUMP WILL NOT INCREASE OR DECREASE IN SUCTION. SHE IS HAVING AN ISSUE WITH HER BOTTLE AND CONNECTOR ATTACHING. ON 6/1/23, THE CUSTOMER CALLED MEDELA TO TROUBLESHOOT HER PUMP AND STATED SHE HAD MASTITIS AND IS TAKING ANTIBIOTICS. SHE IS USING A MANUAL PUMP AT THIS TIME.
Patient problems: Inflammation
MAUDE report 17133732 ↗InjuryMay 18, 2023Suction Problem; Suction Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW BREAST PUMP WAS NOT WORKING FOR HER AND THAT SHE WAS ABLE TO EXPRESS MORE WITH THE SYMPHONY BREAST PUMP. ADDITIONALLY, SHE ALLEGED THAT SHE DEVELOPED MASTITIS AND IS BEING TREATED WITH AN ANTIBIOTIC.
Patient problems: Inflammation
MAUDE report 16955274 ↗InjuryMay 11, 2023Suction Problem; Suction Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC WHILE USING HER PUMP IN STYLE WITH MAXFLOW PUMP SHE WAS EXPERIENCING LOW HUMAN MILK EXPRESSION. THE CUSTOMER ALSO ALLEGED SHE DEVELOPED MASTITIS AND VISITED THE DOCTOR ON (B)(6) 2023 AND WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Inflammation
MAUDE report 16910767 ↗InjuryMay 4, 2023Suction Problem; Suction Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE MAX FLOW BREAST PUMP. SHE ADDITIONALLY ALLEGED SHE HAD MASTITIS AND CLOGGED DUCTS AND WAS WAITING FOR AN ANTIBIOTIC DUE TO HER PUMP NOW WORKING.
Patient problems: Inflammation
MAUDE report 16869313 ↗InjuryApr 14, 2023Suction Failure; Suction Failure
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW HAD LOW SUCTION. ADDITIONALLY, THE CUSTOMER ALLEGED THAT SHE DEVELOPED MASTITIS AND WENT TO THE EMERGENCY ROOM WHERE THE DOCTOR PRESCRIBED AN ANTIBIOTIC. THE CUSTOMER ALSO ALLEGED THAT SHE USED A HOSPITAL GRADE PUMP WHILE THERE TO HELP HER PULL THE MILK OUT.
Patient problems: Inflammation
MAUDE report 16742213 ↗InjuryApr 14, 2023Suction Failure; Suction Failure
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW BREAST PUMP WAS NOT WORKING PROPERLY, AND IT CAUSED HER TO DEVELOP MASTITIS. SHE WENT TO HER DOCTOR AND WAS PRESCRIBED AN ANTIBIOTIC.
Patient problems: Inflammation
MAUDE report 16742093 ↗InjuryMar 6, 2023Pumping Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED THAT SHE HAD LOW SUCTION ON HER PUMP IN STYLE MAX FLOW BREAST PUMP. ADDITIONALLY, THE CUSTOMER ALLEGED THAT SHE DEVELOPED MASTITIS TWICE DUE TO THE PUMP NOT SUCTIONING.
Patient problems: Bacterial Infection
MAUDE report 16484709 ↗InjuryFeb 23, 2023Decrease in Suction
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE MAX FLOW BREAST PUMP. SHE ADDITIONALLY ALLEGED SHE HAD MASTITIS AND WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 16428175 ↗InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING PAIN WHILE USING HER PUMP IN STYLE MAX FLOW BREAST PUMP. SHE ADDITIONALLY ALLEGED THAT SHE HAS MASTITIS AND WAS VERY SORE. SHE IS TAKING AN ANTIBIOTIC.
Patient problems: Bacterial Infection; Pain
MAUDE report 16291263 ↗
Other Pump, Breast, Powered devices
- 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 In Style 101041265Medela LLC · Pump, Breast, Powered20 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.
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