Pump In Style Advanced PNSA Starter Pump (UDI 00020451350776)Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00020451350776), received between Mar 22, 2019 and Oct 25, 2022 — classified as 81 injuries, 1 malfunction.

The most frequently reported specific device problem is “Decrease in Suction” (40 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 82 reports, 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 ↗
• 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 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; 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 ↗
• InjuryFeb 12, 2021Decrease in Suction

  ON (B)(6) 2021 THE CUSTOMER ALLEGED SHE HAD LOW SUCTION WITH HER PUMP IN STYLE BREAST PUMP. SHE ADDITIONALLY ALLEGED SHE HAD MASTITIS, WAS TREATED WITH ANTIBIOTICS, AND WAS SIZED FOR BREAST SHIELDS AT THE HOSPITAL.

  Patient problems: Bacterial Infection

  MAUDE report 11324010 ↗
• InjuryJan 28, 2021Noise, Audible

  ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE STARTER BREAST PUMP WAS MAKING A SKIPPING SOUND, BUT THEN KEEPS GOING. SHE ALSO ALLEGED SHE HAD MASTITIS AND HAS BEEN ON ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 11244800 ↗
• InjuryJan 25, 2021Suction Problem

  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 INDICATED SHE HAD MASTITIS AROUND THANKSGIVING AND WAS ON AN ANTIBIOTIC.

  Patient problems: Unspecified Infection

  MAUDE report 11222405 ↗
• InjuryJan 20, 2021Microbial Contamination of Device

  ON (B)(6) 2020, THE CUSTOMERS' HUSBAND ALLEGED TO MEDELA LLC THAT HIS WIFE HAD A STAPH INFECTION, WHICH THEY WERE TOLD BY THEIR LACTATION CONSULTANT WAS ATTRIBUTED TO THE USE OF THE PUMP IN STYLE BREAST PUMP THAT SHE BELIEVED WAS AN OPEN SYSTEM. ADDITIONALLY, HE ALLEGED THAT HIS WIFE WAS PRESCRIBED MEDICATION.

  Patient problems: Bacterial Infection

  MAUDE report 11203573 ↗
• InjuryJan 15, 2021Decrease in Suction

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE STARTER BREAST PUMP. SHE HAS REPLACED THE TUBING, DUE TO CONDENSATION AND HAS A LOT OF EXTRA PARTS. SHE INDICATED SHE HAD A YEAST INFECTION TWICE ON HER NIPPLE.

  Patient problems: Fungal Infection

  MAUDE report 11177746 ↗
• InjuryDec 15, 2020Decrease in Suction

  ON 12/02/2020, THE CUSTOMER CONTACTED MEDELA LLC ALLEGING THAT HER SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE STARTER BREAST PUMP. SHE ALSO ALLEGED SHE HAS MASTITIS AND HAS BEEN TAKING ANTIBIOTICS FOR NINE DAYS.

  Patient problems: Unspecified Infection

  MAUDE report 11011404 ↗
• InjuryDec 7, 2020Decrease in Suction

  ON 11/16/2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE SUCTION ON HER PUMP IN STYLE BREAST PUMP WAS LOW AND INDICATED THAT SHE IS CURRENTLY PUMPING AT MIDPOINT AS IT HURTS TO GO HIGHER. ADDITIONALLY, SHE ALLEGED THAT THE PUMP IS NOT EMPTYING HER BREAST AND SHE DEVELOPED MASTITIS, WHICH SHE JUST FINISHED HER MEDICATION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10958117 ↗
• InjuryDec 7, 2020Decrease in Suction

  ON 11/25/20, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE STARTER BREAST PUMP. SHE ALSO ALLEGED SHE HAD MASTITIS AND WENT TO THE DOCTOR AND WAS TAKING MEDICATION.

  Patient problems: Unspecified Infection

  MAUDE report 10957949 ↗
• InjuryNov 17, 2020Break

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE HAD A BROKEN FACEPLATE PORT, AND SHE HAD MASTITIS DUE TO NOT BEING ABLE TO PUMP.

  Patient problems: Inflammation

  MAUDE report 10854159 ↗
• InjuryNov 17, 2020Decrease in Suction

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE SUCTION ON HER PUMP IN STYLE BREAST PUMP WAS LOW AND SHE KEEPS GETTING MASTITIS.

  Patient problems: Inflammation

  MAUDE report 10850941 ↗
• InjuryNov 3, 2020Mechanical Problem

  ON 10/13/2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WAS STUCK ON THE HIGHEST SPEED AT TIMES AND PUMPING IS VERY PAINFUL. THE CUSTOMER ALLEGED THAT AT OTHER TIMES IT IS STUCK ON THE LOWEST SPEED AND CHANGES SPEEDS AND PHASES ON IT'S OWN. THE CUSTOMER ALSO ALLEGED THAT SHE HAD MASTITIS AND WAS PRESCRIBED AN ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 10777482 ↗
• InjuryOct 23, 2020Break; Decrease in Suction

  ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE SUCTION ON HER PUMP IN STYLE BREAST PUMP WOULD NOT INCREASE AND THE LETDOWN BUTTON WAS BROKEN. ADDITIONALLY, SHE ALLEGED THAT SHE HAD MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC.

  Patient problems: Unspecified Infection

  MAUDE report 10725658 ↗
• InjuryOct 20, 2020Decrease in Suction

  ON SEPTEMBER 25, 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD LOW SUCTION AND SHE HAD MASTITIS. SHE ADDITIONALLY ALLEGED THAT SHE HAD BEEN PRESCRIBED ANTIBIOTICS, BUT WAS NOT SURE IF THE MASTITIS WAS CAUSED BY THE PUMP.

  Patient problems: Bacterial Infection

  MAUDE report 10706169 ↗

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 · Terminated
  Pump 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