Pump In Style 101041361Recalls & 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. Reports mostly describe loss of suction or power problems, with users mentioning breast inflammation and infection such as mastitis. 41 reports naming its identifier mention no deaths and 39 injuries. 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
- 41
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00020451401454), received between Sep 29, 2020 and Aug 26, 2024 — classified as 39 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Suction Problem” (15 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
- Suction Problem15
- Decrease in Suction10
- Suction Failure3
- Adverse Event Without Identified Device or Use Problem2
- Fire2
- Power Problem2
- Device Emits Odor1
- Failure to Power Up1
Patient problems
- Unspecified Infection16
- Inflammation12
- Bacterial Infection6
- Insufficient Information4
- Pain3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Blister1
- Breast Feeding Problem1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2024Suction Problem; Suction Problem
ON (B)(6) 2024, THE CUSTOMER EMAILED MEDELA LLC THAT SHE NOTICED HER PUMP IN STYLE BREAST PUMP STRENGTH WAS WEAKER THAN WHEN SHE FIRST STATED TO USE IT. ADDITIONALLY, SHE ALLEGED THAT SHE WAS DEALING WITH MASTITIS.
Patient problems: Inflammation
MAUDE report 20065794 ↗InjuryFeb 20, 2024Suction Problem; Suction Problem
ON 02/06/2024, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE BREAST PUMP. SHE ADDITIONALLY ALLEGED THAT SHE HAD MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC.
Patient problems: Inflammation
MAUDE report 18738136 ↗InjuryFeb 12, 2024Suction Problem; Suction Problem
ON (B)(6) 2024, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD LOW SUCTION. ADDITIONALLY, SHE ALLEGED THAT SHE DEVELOPED MASTITIS AND SOUGHT MEDICAL ATTENTION.
Patient problems: Inflammation
MAUDE report 18690096 ↗InjuryDec 8, 2023Suction Problem; Suction Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE WITH MAXFLOW PUMP HAD THE TUBING STUCK IN IT. THE CUSTOMER THEN CALLED BACK ON (B)(6) 2023, HAVING ISSUES WITH LOW SUCTION AND PUMP NOT POWERING ON UNLESS THE POWER CORD WAS HELD A CERTAIN WAY. THE CUSTOMER ALSO ALLEGED SHE HAD MASTITIS TWICE.
Patient problems: Inflammation
MAUDE report 18290184 ↗InjuryOct 31, 2023Power Problem; Power Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE WITH MAXFLOW PUMP WAS HAVING POWER ISSUES. THE CUSTOMER ALSO ALLEGED SHE HAD DEVELOPED MASTITIS DUE TO NOT BEING ABLE TO PUMP HER BREAST MILK, SHE SAID SHE WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Inflammation
MAUDE report 18039121 ↗InjuryOct 10, 2023Suction Problem; Suction Problem
ON (B)(6) 2023, THE CUSTOMER EMAILED MEDELA LLC AND ALLEGED THAT HER PUMP IN STYLE MAX FLOW BREAST PUMP WAS TAKING LONGER FOR HER TO EXPRESS HER MILK AND HER PUMP WAS SOUNDING STRANGE. THE CUSTOMER CALLED MEDELA TO TROUBLESHOOT ON (B)(6) 2023 AND REPORTED SHE HAD MASTITIS DUE TO THE LOW SUCTION WITH HER BREAST PUMP. SHE DID SEEK MEDICAL ATTENTION.
Patient problems: Inflammation
MAUDE report 17903652 ↗InjurySep 13, 2023Power Problem; Power Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE WITH MAXFLOW PUMP STOPPED POWERING ON. THE CUSTOMER ALSO ALLEGED SHE HAD DEVELOPED MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC.
Patient problems: Inflammation
MAUDE report 17738637 ↗InjurySep 11, 2023Suction Problem; Suction Problem
ON (B)(6) 2023, THE CUSTOMER CONTACTED MEDELA LLC CUSTOMER SERVICE VIA EMAIL AND ALLEGED THAT HER MEDELA PUMP IN STYLE BREAST PUMP SUDDENLY STOPPED WORKING. ADDITIONALLY, THE CUSTOMER ALLEGED THAT SHE HAS MASTITIS. CUSTOMER SERVICE SENT TROUBLESHOOTING TIPS VIA EMAIL AND ADVISED THE CUSTOMER TO CALL IN IF THE ISSUE WAS NOT RESOLVED WITH THE TROUBLESHOOTING TIPS. ON (B)(6) 2023, THE CUSTOMER CALLED MEDELA LLC TO TROUBLESHOOT HER PUMP.
Patient problems: Inflammation
MAUDE report 17719444 ↗InjuryJun 8, 2023Suction Problem; Suction Problem
ON 6/6/2023, THE CUSTOMER ALLEGED SHE HAD MASTITIS WHILE USING HER PUMP IN STYLE BREAST PUMP. SHE ALLEGED THE ISSUE THAT LED TO HER MASTITIS WAS THE YELLOW MEMBRANE WOULD NOT CLOSE ON THE CONNECTOR AND THIS WAS CAUSING LOW SUCTION WITH HER PUMP. SHE WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Inflammation
MAUDE report 17089343 ↗InjuryMar 3, 2023Unintended Collision
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP FELL AND NOW IT IS NOT PUMPING RIGHT. ON (B)(6) 2023, THE CUSTOMER CALLED BACK AND ALLEGED THAT HER PUMP IN STYLE BREAST PUMP NOW HAS LOW SUCTION AND ALLEGED THAT SHE DEVELOPED MASTITIS TWICE, ONCE IN NOVEMBER AND AGAIN IN DECEMBER; BUT WAS NOT SURE IF IT WAS FROM THE PUMP. ADDITIONALLY, THE CUSTOMER ALLEGED THAT SHE DID SEEK MEDICAL ATTENTION. THE CUSTOMER ALSO ALLEGED THAT SHE TRIED TO USE THE BATTERY PACK AND IT CREATED SMOKE.
Patient problems: Unspecified Infection
MAUDE report 16476953 ↗InjuryJan 18, 2023Suction Problem
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. SHE ADDITIONALLY ALLEGED SHE HAD MASTITIS DUE TO THE PUMP NOT WORKING FOR HER. SHE WENT TO HER DOCTOR AND WAS PRESCRIBED ANTIBIOTICS FOR MASTITIS.
Patient problems: Bacterial Infection; Inflammation
MAUDE report 16197748 ↗InjuryJan 6, 2023Decrease in Suction; Mechanical Problem
ON 12/14/2022, THE CUSTOMER ALLEGED TO MEDELA LLC WHILE USING HER PUMP IN STYLE MAXFLOW PUMP THE MOTOR BEGAN TO MAKE AN UNFAMILIAR NOISE AND IT LOST SUCTION AFTER THE LETDOWN MODE. THE CUSTOMER ALSO STATED SHE HAS NOTICED THE PUMP HAS NOT BEEN EXPRESSING AS MUCH MILK AS IT USED TO. THE CUSTOMER ALSO ALLEGED SHE WAS DIAGNOSED WITH MASTITIS TWICE IN THE PAST TWO MONTHS OF USING THE PUMP.
Patient problems: Bacterial Infection; Breast Feeding Problem; Inflammation
MAUDE report 16112953 ↗InjuryDec 2, 2022Output Problem
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC WHILE USING HER PUMP IN STYLE MAXFLOW THE VIBRATION WAS PAINFUL AND SHE WAS UNABLE TO FULLY EXPRESS HER HUMAN MILK. THE CUSTOMER ALSO ALLEGED SHE DEVELOPED MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC TO TREAT IT.
Patient problems: Pain; Unspecified Infection
MAUDE report 15904264 ↗InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2022, THE CUSTOMER ALLEGED VIA EMAIL THAT SHE HAD THE PUMP IN STYLE BREAST PUMP AND SHE SUFFERED FROM MASTITIS TWICE AND HAD TO BE MEDICATED. ADDITIONALLY, SHE ALLEGED THAT IN ORDER TO HEAL FROM SEVERAL BOUTS OF NIPPLE BLISTERS, CRACKS AND BLEEDING, SHE PURCHASED A HARMONY MANUAL BREAST PUMP, WHICH WAS A LIFE SAVER. THE CUSTOMER ALLEGED THAT SHE NEEDED ASSISTANCE AND GUIDANCE ON THE HARMONY PUMP AND ATTACHED PICTURES OF THE OF THE UPC AND PRODUCT NUMBER.
Patient problems: Blister; Unspecified Infection
MAUDE report 15459035 ↗InjurySep 6, 2022Decrease in Suction
ON 08/18/2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE MAX FLOW BREAST PUMP. SHE ADDITIONALLY REPORTED SHE WAS AT THE HOSPITAL WITH CLOGGED DUCTS AND MASTITIS. SHE WE RECEIVING ANTIBIOTICS VIA IV DRIP.
Patient problems: Obstruction/Occlusion; Unspecified Infection
MAUDE report 15364161 ↗InjuryJul 13, 2022Suction Problem
ON (B)(6) 2022, THE CUSTOMER ALLEGED HER PUMP IN STYLE MAXFLOW BREAST PUMP STOPPED SUCTIONING. THE CUSTOMER ALLEGED SHE WAS DIAGNOSED WITH MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC.
Patient problems: Unspecified Infection
MAUDE report 15007700 ↗MalfunctionJul 13, 2022Fire; Device Emits Odor
ON 6/30/2022, THE CUSTOMER ALLEGED TO MEDELA LLC SHE NOTICED AN ELECTRICAL ODOR COMING FROM HER BACKPACK WHICH CONTAINED HER UNPLUGGED PUMP IN STYLE MAXFLOW BATTERY PACK. SHE ALSO ALLEGED TO HAVE SEEN FLAMES COMING FROM THE BATTERY PACK.
Patient problems: Insufficient Information
MAUDE report 14999877 ↗InjuryJul 13, 2022Suction Failure
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC WHILE USING HER PUMP IN STYLE MAXFLOW HER PUMP STOPPED SUCTIONING. ADDITIONALLY THE CUSTOMER ALLEGED SHE DEVELOPED MASTITIS AND WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 14999873 ↗InjuryJun 23, 2022Suction Problem
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW HAD A MILK BACKUP. ADDITIONALLY SHE ALLEGED THAT SHE HAD MASTITIS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14792062 ↗InjuryMay 24, 2022Suction Problem; Noise, Audible
ON (B)(6) 2022, THE CUSTOMER EMAILED MEDELA IN (B)(6) AND ALLEGED THAT SHE RECEIVED A PUMP IN STYLE MAX FLOW FOR HER BABY SHOWER AND IT WAS NOT WORKING VERY WELL. SHE ADDITIONALLY ALLEGED THAT SHE IS GETTING CLOGGED DUCTS AND HAD MASTITIS TWICE. SHE HAS BEEN FITTED FOR THE CORRECT BREAST SHIELDS AND SHE HAS BOUGHT NEW PARTS AND CLEANS/DRIES THEM PROPERLY AND HER PUMP IS NOT SOUNDING RIGHT.
Patient problems: Unspecified Infection
MAUDE report 14488806 ↗InjuryMay 18, 2022Suction Problem
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS HAVING A DELAY IN SUCTION WITH HER PUMP IN STYLE MAX FLOW BREAST PUMP. SHE ADDITIONALLY ALLEGED SHE DEVELOPED MASTITIS FROM NOT BEING ABLE TO PUMP. SHE HAS BEEN PRESCRIBED ANTIBIOTICS BY HER PHYSICIAN.
Patient problems: Unspecified Infection
MAUDE report 14427372 ↗InjuryMay 10, 2022Suction Failure
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE HAD NO SUCTION WITH HER PUMP IN STYLE MAX FLOW BREAST PUMP. SHE ADDITIONALLY ALLEGED SHE HAD MASTITIS.
Patient problems: Bacterial Infection
MAUDE report 14349279 ↗InjuryMar 18, 2022Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW BREAST PUMP WAS NOT EXPRESSING HER. HER PUMP IN STYLE ADVANCED BREAST PUMP WORKED MUCH BETTER FOR HER. THE CUSTOMER DEVELOPED CLOGGED DUCTS AND A BREAST INFECTION FROM USING HER MAX FLOW BREAST PUMP. THE CUSTOMER DOESN'T BELIEVE THE MAX FLOW WORKS WELL FOR HER.
Patient problems: Unspecified Infection
MAUDE report 13806590 ↗MalfunctionMar 8, 2022Fire
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW BREAST PUMP CAUGHT FIRE WHILE PLUGGED INTO A WALL OUTLET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13686385 ↗InjuryMar 3, 2022Suction Problem
ON FEBRUARY 23, 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAXFLOW WAS NOT RELEASING THE SUCTION, WHICH CAUSED MASTITIS AND CLOGGED DUCTS AFTER FIVE DAYS OF USING IT.
Patient problems: Bacterial Infection
MAUDE report 13663494 ↗
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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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