Pump In Style 101041359Recalls & reported problems
Medela LLC · Powered Double Breast Pump · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00020451401430), received between Apr 5, 2022 and Apr 4, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Decrease in Suction” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Decrease in Suction1
- Suction Problem1
Patient problems
- Bacterial Infection1
- Inflammation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2023Suction Problem; Suction Problem
ON (B)(6) 2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW HAD LOW SUCTION, A HIGH SQUEAKING NOISE AND VIBRATES SO MUCH THAT IT WALKED OFF THE TABLE. ADDITIONALLY, SHE ALLEGED THAT SHE DEVELOPED MASTITIS AND WAS ON AN ANTIBIOTIC.
Patient problems: Inflammation
MAUDE report 16672772 ↗InjuryApr 5, 2022Decrease in Suction
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA, LLC THE SHE HAS LOW SUCTION WITH HER PUMP IN STYLE MAX FLOW. ADDITIONALLY SHE ALLEGED THAT SHE THINKS SHE HAS MASTITIS AND IS GOING TO GET AN ANTIBIOTIC.
Patient problems: Bacterial Infection
MAUDE report 14013633 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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