Pump In StyleRecalls & reported problems across all models
Medela LLC · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 191
- Deaths reported
- 0
- Injuries reported
- 189
- Recalls
- 0
We found 5 models of Pump In Style by Medela LLC in the FDA's device registry (GUDID). Together they are named in 191 adverse event reports in the FDA's MAUDE database, received between Sep 29, 2020 and Apr 8, 2026 — classified as 189 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Decrease in Suction” (63 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Pump In Style problems
Device problems
- Decrease in Suction63
- Suction Problem54
- Power Problem12
- Adverse Event Without Identified Device or Use Problem10
- Suction Failure9
- Failure to Power Up8
- Therapeutic or Diagnostic Output Failure7
- Noise, Audible6
Patient problems
- Unspecified Infection95
- Inflammation56
- Bacterial Infection19
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
- Insufficient Information8
- Pain7
- Obstruction/Occlusion6
- Blister2
Pump In Style models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Pump In Style 101041360Pump, Breast, Powered127 reports
- Pump In Style 101041361Pump, Breast, Powered41 reports
- Pump In Style 101041265Pump, Breast, Powered20 reports
- Pump In Style 101041359Pump, Breast, Powered2 reports
- Pump In Style 101041362Pump, Breast, Powered1 report
Recent Pump In Style adverse event reports
The 15 most recent reports across all models, 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 ↗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 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 ↗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 ↗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 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 ↗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 ↗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 ↗
Other Medela LLC products
All Medela LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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