Pump In Style AdvancedRecalls & reported problems across all models
Medela LLC · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 139
- Deaths reported
- 0
- Injuries reported
- 134
- Recalls
- 0
We found 9 models of Pump In Style Advanced by Medela LLC in the FDA's device registry (GUDID). Together they are named in 139 adverse event reports in the FDA's MAUDE database, received between Jan 23, 2017 and Oct 25, 2022 — classified as 134 injuries, 5 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
Most reported Pump In Style Advanced problems
Device problems
- Decrease in Suction63
- Suction Problem27
- Noise, Audible8
- Break7
- Device Operates Differently Than Expected5
- Failure to Power Up5
- Adverse Event Without Identified Device or Use Problem4
- Patient-Device Incompatibility4
Patient problems
- Unspecified Infection78
- Pain21
- Inflammation19
- Bacterial Infection9
- No Known Impact Or Consequence To Patient5
- Rash5
- Fungal Infection4
- No Information4
Pump In Style Advanced models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Pump In Style Advanced PNSA Starter PumpPump, Breast, Powered82 reports
- Pump in Style Advanced PNSA Starter PumpPump, Breast, Powered23 reports
- Pump In Style Advanced PNSA TotePump, Breast, Powered11 reports
- Pump In Style Advanced PNSA TotePump, Breast, Powered8 reports
- Pump In Style Advanced Pump In Style Advance BackpackPump, Breast, Powered7 reports
- Pump In Style Advanced Pump In Style Advance BackpackPump, Breast, Powered3 reports
- Pump In Style Advanced Advanced Personal Double Starter Breast PumpPump, Breast, Powered2 reports
- Pump In Style Advanced Advanced Personal Double Breast PumpPump, Breast, Powered2 reports
- Pump In Style Advanced Advanced Personal Double Breast PumpPump, Breast, Powered1 report
Recent Pump In Style Advanced adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 25, 2022Improper or Incorrect Procedure or Method
ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE FELL ASLEEP WHILE USING HER PUMP IN STYLE BREAST PUMP AND THE CORD THAT CONNECTS TO THE PUMP CAME LOOSE AND BURNED HER ONE BREAST AND LEG. ADDITIONALLY SHE ALLEGED THAT SHE IS GOING TO THE EMERGENCY ROOM.
Patient problems: Superficial (First Degree) Burn
MAUDE report 15667944 ↗InjuryMar 9, 2022Failure to Power Up; Suction Problem
ON (B)(6) 2022 THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE ADVANCED BREAST PUMP WOULD NOT TURN ON OR SUCTION CORRECTLY, WHICH HAD CAUSED HER TO GO TO THE HOSPITAL WHERE SHE WAS DIAGNOSED WITH MASTITIS AND PRESCRIBED ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 13711377 ↗InjuryNov 19, 2021Therapeutic or Diagnostic Output Failure
ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE STARTER BREAST PUMP WAS NOT EXPRESSING HER, IT GOT TO THE POINT THAT SHE HAD MASTITIS AND WAS SITTING AND PUMPING FOR 40 MINUTES.
Patient problems: Unspecified Infection
MAUDE report 12843945 ↗InjuryOct 7, 2021Decrease in Suction
ON (B)(6) 2021 THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE PUMP IN STYLE ADVANCED BREAST PUMP HAD LOW SUCTION AND SHE WAS NOT ABLE TO EXPRESS HER BREAST MILK, WHICH LED TO MASTITIS.
Patient problems: Unspecified Infection
MAUDE report 12594777 ↗InjuryJun 7, 2021Decrease in Suction
ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE BREAST PUMP. SHE ALSO ALLEGED THAT SHE HAD MASTITIS.
Patient problems: Unspecified Infection
MAUDE report 11951983 ↗InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2021 THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WAS CAUSING PAIN AND SHE HAD SORES AT THE BASE OF HER NIPPLES. SHE ADDITIONALLY ALLEGED THAT SHE HAD ALREADY TRIED SMALLER BREAST SHIELDS AND HER DOCTOR HAD CONFIRMED THE PAIN WAS CAUSED BY THE PUMP AND NOT THE BABY.
Patient problems: Pain; Unspecified Tissue Injury
MAUDE report 11821405 ↗InjuryApr 26, 2021Decrease in Suction
ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER SUCTION WAS UNEVEN WITH HER PUMP IN STYLE STARTER BREAST PUMP. SHE ALSO ALLEGED THAT THE SUCTION HAS BEEN LOW SINCE SHE RECEIVED HER PUMP 6 MONTHS AGO AND SHE HAS EXPERIENCED CLOGGED DUCTS AND MASTITIS, WHICH ARE BOTH RESOLVED. SHE HAD NOT PREVIOUSLY REACHED OUT TO MEDELA LLC FOR ASSISTANCE.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 11725857 ↗InjuryApr 20, 2021Decrease in Suction
ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE STARTER BREAST PUMP. SHE STATED IT SOUNDED LIKE HER PUMP WAS STRUGGLING AND SHE HAD NEW PARTS. SHE ALSO ALLEGED SHE HAD MASTITIS THREE TIME AND HAD TAKEN ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 11694228 ↗InjuryApr 8, 2021Decrease in Suction
ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD LOW SUCTION. ON (B)(6) 2021, THE CUSTOMER CALLED BACK AND ALLEGED THAT THE REPLACEMENT PARTS DID NOT RESOLVE THE SUCTION ISSUE AND SHE HAS THE PUMP TURNED ALL THE WAY UP. ADDITIONALLY SHE ALLEGED SHE HAS MASTITIS. IN FOLLOW UP WITH A COMPLAINT HANDLER ON 03/23/2021, THE CUSTOMER INDICATED THAT SHE DEVELOPED MASTITIS ON (B)(6) 2021. (03/23/21 BECOMES OUR AWARE DATE AS WE LEARNED THE CUSTOMER WAS PRESCRIBED ANTIBIOTICS TO TREAT HER MASTITIS.)
Patient problems: Unspecified Infection
MAUDE report 11635173 ↗InjuryMar 17, 2021Decrease in Suction
ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE HAS AN INFECTION AND WAS ADMITTED INTO THE HOSPITAL DUE TO HER PUMP IN STYLE BREAST PUMP HAVING LOW SUCTION.
Patient problems: Unspecified Infection
MAUDE report 11506554 ↗InjuryMar 12, 2021Decrease in Suction
ON (B)(6), 2021 THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD LOW SUCTION AND SHE HAD MASTITIS. SHE ADDITIONALLY ALLEGED THAT HER DOCTOR HAD PRESCRIBED HER TWO MEDICATIONS AND THERE WAS BLOOD IN HER MILK, BUT SHE WAS ALSO USING THE HARMONY PUMP AND IT WAS WORKING FINE.
Patient problems: Unspecified Infection
MAUDE report 11475836 ↗InjuryMar 11, 2021Decrease in Suction
ON (B)(6) 2021 THE CUSTOMER ALLEGED VIA EMAIL TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD VERY LITTLE SUCTION EVEN AFTER CHECKING ALL HER PUMP PARTS AND DIAPHRAGM FOR WEAR. THE CUSTOMER ALSO ALLEGED THAT SHE BOUGHT REPLACEMENT PARTS WHICH DID NOT HELP AND SHE DEVELOPED MASTITIS 3 TIMES WITHIN A MONTH.
Patient problems: Unspecified Infection
MAUDE report 11465680 ↗InjuryMar 11, 2021Decrease in Suction; Overheating of Device; Key or Button Unresponsive/not Working
ON (B)(6) /2021, THE CUSTOMER CONTACTED MEDELA LLC VIA CHAT AND ALLEGED THAT HER LETDOWN BUTTON WAS NO LONGER WORKING ON HER PUMP IN STYLE BREAST PUMP. SHE FURTHER ALLEGED THAT HER PUMP GETS VERY HOT AND THE SUCTION WILL DECREASE DRASTICALLY. SHE WAS PUMPING EVERY 2 HOURS AND ENDED UP GETTING MASTITIS. SHE WAS ADVISED OF TREATMENT OF THE MASTITIS AND STARTED USING A HAND PUMP. SHE WAS TREATED FOR THE MASTITIS ON (B)(6) 2021, AFTER VISITING HER DOCTOR AND THE MASTITIS IS STARTING TO GO AWAY AFTER SHE TOOK A WEEK OF ANTIBIOTICS.
Patient problems: Bacterial Infection
MAUDE report 11462412 ↗InjuryFeb 17, 2021Suction Problem
ON (B)(6) 2021 THE CUSTOMER ALLEGED THAT WHEN USING HER PUMP IN STYLE BREAST PUMP SHE HAS TO INCREASE THE SUCTION TO THE MAXIMUM LEVEL WHILE IN THE FIRST PHASE TO GET SUCTION BUT DECREASE THE SUCTION WHEN SHE IS IN THE SECOND PHASE. SHE ALSO ALLEGED THAT SHE HAD CLOGGED DUCTS AND MASTITIS BACK IN (B)(6) AND WAS PRESCRIBED AN ANTIBIOTIC. SHE ALSO INDICATED THAT SHE HAS USED ANOTHER PUMP IN STYLE BREAST PUMP AND IT HAS A PERFORMANCE THAT THIS PUMP DOES NOT HAVE.
Patient problems: Unspecified Infection
MAUDE report 11338841 ↗InjuryFeb 12, 2021Patient Device Interaction Problem
ON (B)(6) 2021, THE CUSTOMER ALLEGED SHE HAD DEVELOPED A RASH FROM USING THE MEDELA PUMP IN STYLE PERSONAL FIT 21MM BREAST SHIELDS. SHE ADDITIONALLY ALLEGED SHE HAD BEEN PRESCRIBED A STEROID CREAM.
Patient problems: Rash
MAUDE report 11324043 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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