Pump In Style Advanced Advanced Personal Double Starter Breast PumpRecalls & reported problems
Medela LLC · Powered Double Breast Pump · Class 2
All models of Pump In Style Advanced (9)
Data updated Oct 18, 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 00020451350783), received between Dec 11, 2018 and Feb 5, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Decrease in Suction” (1 report).
1 other recall cover devices cleared under the same FDA submission (K031614); they may or may not involve this specific model.
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 18, 2026.
Most reported problems
Device problems
- Decrease in Suction1
- Patient-Device Incompatibility1
Patient problems
- Rash1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 5, 2019Patient-Device Incompatibility
ON (B)(6) 2019 THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE HAD BEEN USING HER PUMP IN STYLE BREAST PUMP FOR 4 MONTHS AND OVER THE LAST 2-1/2 MONTHS, HAS HAD A RASH WHERE THE BREAST SHIELDS MAKE CONTACT WITH HER BREASTS. THOUGH UNSURE IF SHE IS ALLERGIC TO THE BREAST SHIELDS, SHE SPOKE WITH A DERMATOLOGIST AND WAS GIVEN CREAM WHICH DID NOT HELP.
Patient problems: Rash
MAUDE report 8304691 ↗InjuryDec 11, 2018Decrease in Suction
ON 10/23/2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP SOUNDED WEAK AND WAS NOT PROVIDING ENOUGH SUCTION TO EMPTY HER BREASTS. SHE ADDITIONALLY ALLEGED THAT SHE HAD MASTITIS TWICE, ONCE IN ONE BREAST, AND A SECOND TIME IN BOTH BREASTS. SHE SAW A DOCTOR WHO TOLD HER THE MASTITIS WAS CAUSED BY THE PUMP BECAUSE IT WAS NOT EMPTYING HER ALL OF THE WAY.
Patient problems: Unspecified Infection
MAUDE report 8151845 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K031614. One submission often covers many models, so check the product and lot details in each record.
- Z-1224-2011 · Jan 10, 2011 · TerminatedPump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Dri
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 In Style 101041265Medela LLC · Pump, Breast, Powered20 reports
- Pump Kit, Gen 3 (2S), 2PK, White, 24mm PDW48Willow Innovations, Inc. · Pump, Breast, Powered14 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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