Pump in Style Advanced PNSA Starter Pump (REF 57081)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00020451570815), received between Jan 23, 2017 and Nov 14, 2019 — classified as 21 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2019Patient-Device Incompatibility

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE HAD AN ALLERGIC REACTION TO THE PERSONAL FIT 24 MM BREAST SHIELDS SHE WAS USING WITH HER PUMP IN STYLE BREAST PUMP. SHE ADDITIONALLY ALLEGED THAT SHE HAD HIVES AND HAD SEEN A DOCTOR, WHO PRESCRIBED HER A STEROID MEDICATION.

  Patient problems: Reaction; Urticaria

  MAUDE report 9320774 ↗
• InjurySep 26, 2019Fungus in Device Environment

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THERE WAS MOLD IN THE TUBING FOR HER PUMP IN STYLE BREAST PUMP.

  Patient problems: No Information

  MAUDE report 9123134 ↗
• InjuryApr 29, 2019Suction Failure

  ON (B)(6) 2019, THE CUSTOMER ALLEGED VIA EMAIL TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WHICH SHE HAD BEEN USING FOR LESS THAN ONE YEAR HAD LOST SUCTION, DESPITE HAVING REPLACED THE PARTS/ACCESSORIES ON MULTIPLE OCCASIONS. SHE ADDITIONALLY ALLEGED THAT SHE HAD DEVELOPED MASTITIS TWICE IN ONE WEEK DUE TO IMPROPER DRAINAGE AS A RESULT OF THE PUMP NOT WORKING.

  Patient problems: Unspecified Infection

  MAUDE report 8560664 ↗
• MalfunctionApr 5, 2019Intermittent Loss of Power

  ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WOULD PUMP TWICE AND THEN TURN OFF, EVEN AFTER TRYING A NEW POWER ADAPTER. SHE INDICATED THAT THE PUMP STOPPED WORKING (B)(6) 2019 DURING HER WORK DAY AND SHE HAD TO GO 6 HOURS WITHOUT PUMPING. THE CUSTOMER FURTHER ALLEGED THAT SHE GOT MASTITIS ON (B)(6) 2019, FOR WHICH SHE WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 8488051 ↗
• InjuryJan 23, 2019Defective Component; Noise, Audible

  ON (B)(6) 2018 THE CUSTOMER ALLEGED TO MEDELA LLC VIA EMAIL THAT HER PUMP IN STYLE BREAST PUMP STARTED MAKING A "CRICKET" SOUND AND THAT SHE NOW HAS TO SET THE VACUUM LEVEL AT THE HIGHEST SETTING TO EXPRESS ANY MILK, WHEN PREVIOUSLY SHE COULD USE IT ON THE LOWEST SETTING. SHE ADDITIONALLY ALLEGED THAT SHE HAS REPLACED THE PARTS AND CONDUCTED RECOMMENDED TROUBLESHOOTING, WITHOUT ANY IMPROVEMENT, AND NOW HAS CLOGGED DUCTS BECAUSE SHE IS UNABLE TO FULLY EMPTY HER BREASTS.

  Patient problems: No Code Available

  MAUDE report 8270126 ↗
• InjuryJan 10, 2019Suction Problem; Defective Device

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC VIA EMAIL THAT SHE MET WITH A LACTATION CONSULTANT WHO TOLD HER THAT HER PUMP IN STYLE BREAST PUMP WAS DEFECTIVE, THAT THE SUCTION DID NOT SEEM NORMAL AND IT HAS BEEN CAUSING HER SOME NIPPLE DAMAGE. SHE ADDITIONALLY ALLEGED THAT ALL OF THE PARTS AND ACCESSORIES WERE WORKING PROPERLY.

  Patient problems: Pain

  MAUDE report 8235411 ↗
• InjurySep 27, 2018Gas/Air Leak

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WORKED WELL WHEN SHE LEFT THE HOSPITAL, BUT SUBSEQUENTLY SHE NOTICED THAT SOME AIR WAS LEAKING FROM THE PUMP. SHE DIDN'T THINK MUCH OF IT, BUT THEN SHORTLY AFTER, SHE WOKE UP ONE NIGHT WITH PAIN IN HER RIGHT BREAST AND SHE HAD A FEVER. SHE WAS LATER DIAGNOSED WITH MASTITIS IN BOTH BREASTS, FOR WHICH SHE WAS PRESCRIBED ANTIBIOTICS. THE MASTITIS HAS SINCE RESOLVED, BUT SHE CONTINUES TO BATTLE WITH CLOGGED DUCTS. ADDITIONALLY, SHE WAS THEN TOLD ON (B)(6) 2018 THAT HER BABY HAD THRUSH AND A BAD YEAST DIAPER RASH DUE TO HER USE OF ANTIBIOTICS. THE BABY WAS PRESCRIBED A SUSPENSION LIQUID AND A CREAM FOR THE DIAPER RASH. SHE ALLEGED THAT "ALL OF THIS STEMMED FROM AN INEFFECTIVE PUMP" AND FURTHER ALLEGED THAT THE SUCTION HAD BEEN LOWER.

  Patient problems: Fever; Fungus; Pain; Rash

  MAUDE report 7914112 ↗
• InjuryAug 28, 2018Suction Problem

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA (B)(4) THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE BREAST PUMP AND WAS PRESCRIBED ANTIBIOTICS, AS HER BREASTS WERE HARD AND SHE WAS EXPERIENCING BACK PAIN. SHE WAS TOLD BY A FRIEND THAT MEDELA WOULD REPLACE HER PUMP SINCE SHE GOT MASTITIS. SHE ADDITIONALLY ALLEGED THAT SHE ORIGINALLY HAD MASTITIS IN (B)(6) 2017, AT WHICH TIME SHE WAS ALSO PRESCRIBED ANTIBIOTICS.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7822586 ↗
• InjuryJun 18, 2018Patient-Device Incompatibility

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA (B)(4) THAT THE 24MM BREAST SHIELDS SHE WAS USING WITH HER PUMP IN STYLE BREAST PUMP WERE TOO SMALL. THE CUSTOMER ALLEGED THAT SHE WAS HAVING REDNESS, PAIN AND IRRITATION ON HER NIPPLE WHEN PUMPING, THAT IT SEEMED AS IF THE BREAST SHIELD WAS SCRATCHING HER.

  Patient problems: Erythema; Irritation; Pain

  MAUDE report 7610488 ↗
• InjuryMay 18, 2018Suction Problem

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA (B)(4) THAT THE SUCTION ON HER PUMP IN STYLE WAS TOO HIGH, EVEN ON THE LOWEST VACUUM SETTING, AND CAUSED AN OBSTRUCTION ON HER LEFT BREAST, FOR WHICH SHE WAS PRESCRIBED AN ANTIBIOTIC.

  Patient problems: Obstruction/Occlusion

  MAUDE report 7525958 ↗
• InjuryApr 11, 2018Decrease in Suction

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC VIA EMAIL THAT THE PUMP IN STYLE BREAST PUMP WHICH SHE RECEIVED THROUGH HER INSURANCE, WHICH SHE HAD BEEN USING FOR 5 WEEKS, WAS MAKING A STRANGE "GRINDING SOUND." SHE ADDITIONALLY ALLEGED THAT SHE RARELY DOUBLE PUMPS WITH IT BECAUSE THE SUCTION "SUFFERS." AT THIS TIME, THE CUSTOMER MADE NO MENTION OF MASTITIS. CUSTOMER SERVICE EMAILED THE CUSTOMER TROUBLESHOOTING TIPS, WHICH HELPED HER TO IDENTIFY AN ISSUE WITH THE FACEPLATE MOUNTING POSTS, WHICH SHE REPORTED ON (B)(6) 2018. AT THAT TIME, THE CUSTOMER WAS SENT A REPLACEMENT DEVICE. ON (B)(6) 2018, THE SAME CUSTOMER ALLEGED TO MEDELA LLC VIA EMAIL THAT SHE PURCHASED A SWING BREAST PUMP TO USE IN ADDITION TO THE PUMP IN STYLE AND IT WAS "TERRIBLY INEFFECTIVE." SHE ALLEGED THAT AFTER USING IT FOR 10 DAYS, THE SUCTION WAS NEGLIGIBLE EVEN AT HIGH LEVELS AND THAT SHE GETS LITTLE MILK COMPARED TO WHAT SHE GETS WHEN USING THE PUMP IN STYLE. SHE FURTHER ALLEGED THAT SHE HAD CHRONIC MASTITIS. CUSTOMER SERVICE ENCOURAGED THE CUSTOMER TO PHONE IN SO THAT HER ISSUE COULD BE ADDRESSED. SHE PHONED IN ON (B)(6) 2018 AND INDICATED THAT SHE WOULD TEST THE PUMP USING THE POWER SUPPLY AND ALSO WITH N

  Patient problems: Inflammation

  MAUDE report 7422633 ↗
• InjuryFeb 14, 2018Decrease in Suction

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP HAD LOW SUCTION AND SHE HAD MASTITIS, FOR WHICH SHE WAS PRESCRIBED AN ANTIBIOTIC.

  Patient problems: Unspecified Infection

  MAUDE report 7269472 ↗
• InjuryFeb 6, 2018Suction Problem; Device Operates Differently Than Expected

  ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION ON ONE SIDE WITH HER PUMP IN STYLE BREAST PUMP. SHE ADDITIONALLY ALLEGED THAT SHE HAD MASTITIS, FOR WHICH SHE WAS PRESCRIBED AN ANTIBIOTIC.

  Patient problems: Inflammation

  MAUDE report 7243422 ↗
• MalfunctionDec 27, 2017Break; Detachment Of Device Component; Structural Problem

  ON (B)(6) 2017, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE "CASING" FOR THE POWER SUPPLY FOR HER PUMP IN STYLE BREAST PUMP CAME APART, EXPOSING WIRES.

  Patient problems: No Information

  MAUDE report 7149265 ↗
• InjuryDec 22, 2017Decrease in Suction; Device Stops Intermittently

  ON (B)(6) 2017, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WOULD STOP PUMPING AND WOULDN'T POWER BACK ON FOR A FEW MINUTES. THE CUSTOMER ALSO ALLEGED THAT SHE WAS HAVING TO TURN THE PUMP VACUUM UP HIGHER THAN USUAL AND IT WAS HURTING HER NIPPLES.

  Patient problems: Pain

  MAUDE report 7141692 ↗
• InjuryDec 18, 2017Device Operates Differently Than Expected

  ON (B)(6) 2017, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE SUCTION ON HER PUMP IN STYLE BREAST PUMP WAS TOO STRONG, EVEN ON THE MINIMUM SETTING, CAUSING CRACKED AND BLOODY NIPPLES. SHE ALLEGED THAT SHE WENT TO HER LACTATION CONSULTANT AND THEY THOUGHT SHE HAD MASTITIS AND WAS PRESCRIBED ANTIBIOTICS. SHE ALLEGED THAT SHE WAS SIZED FOR THE 24 MM BREAST SHIELDS AND DID NOT HAVE ANY NIPPLE ISSUES WHEN USING THE SYMPHONY BREAST PUMP.

  Patient problems: Irritation; Unspecified Infection

  MAUDE report 7125971 ↗
• InjuryOct 19, 2017Device Operates Differently Than Expected

  ON (B)(6) 2017, THE CUSTOMER REPORTED TO MEDELA LLC THAT SHE WAS EXPERIENCING PAIN WHEN USING THE 21MM AND 24MM BREAST SHIELDS FOR HER PUMP IN STYLE ADVANCE BREAST PUMP. SHE ALSO STATED THE SHE TRIED THE 30MM BREAST SHIELDS AND EXPERIENCED NO PAIN, BUT WAS NOT EXPRESSING MUCH MILK.

  Patient problems: Pain

  MAUDE report 6963495 ↗
• InjuryAug 29, 2017Decrease in Suction

  ON (B)(6) 2017, THE CUSTOMER ALLEGED THAT HER PUMP IN STYLE ADVANCED BREAST PUMP HAD LOW SUCTION AND SHE WAS ENGORGED. SHE ALSO STATED THAT SHE HAD MASTITIS RIGHT AFTER SHE HAD HER BABY.

  Patient problems: Bacterial Infection

  MAUDE report 6826466 ↗
• InjuryAug 25, 2017Decrease in Suction; Pumping Stopped; Noise, Audible

  ON 07/07/2017 THE CUSTOMER ALLEGED THAT THE FIRST TIME SHE STARTED PUMPING WITH THE PUMP IN STYLE BREAST PUMP, IT SOUNDED LIKE THERE WAS A CRICKET INSIDE AND ALL OF A SUDDEN THE PUMP STOPPED SUCTIONING. THE CUSTOMER STATED THAT THIS HAPPENED AROUND (B)(6) 2017 AND IT CAUSED HER TO DEVELOP MASTITIS BECAUSE MILK WASN'T BEING EXPRESSED ON THE LEFT SIDE. THE CUSTOMER REPORTED SHE SAW FIRST SIGNS OF MASTITIS ON THE (B)(6) 2017 AND WENT TO THE DOCTOR ON THE (B)(6) 2017, AND STATED, "THEY HAD TO CUT MY BREAST OPEN ON THAT SIDE" (LEFT BREAST). THEY DID ONE INCISION ON (B)(6) 2017, BUT HAD TO REOPEN IT 3 TIMES AFTERWARDS. SHE WAS PRESCRIBED AN ANTIBIOTIC ON (B)(6) 2017, AND WAS THEN PRESCRIBED A STRONGER ANTIBIOTIC. SHE DID NOT COMPLETE THE ANTIBIOTICS BECAUSE THE BREAST SPECIALISTS RECOMMENDED SHE STOP AS THEY THOUGHT IT WAS BEST TO CONTINUE WITH MORE INCISIONS AND NOT RISK SIDE EFFECTS OF ANTIBIOTICS WHICH DID NOT SEEM TO BE HELPING. SHE HAS A FOLLOW UP VISIT ON (B)(6) 2017 TO CHECK WHETHER ANOTHER INCISION WILL HAVE TO BE MADE FOR THE THIRD LUMP SHE HAS DEVELOPED. AFTER SHE GOT THE INCISIONS, SHE HAD "MULTIPLE ABSCESSES" WHICH ONE OF THEM WAS ABLE TO BE DRAINED WITH A NEEDLE AND THE SECO

  Patient problems: Cyst(s); Skin Inflammation; Tissue Damage; Unspecified Infection

  MAUDE report 6819940 ↗
• InjuryApr 26, 2017Decrease in Suction

  THE CUSTOMER REPORTED TO CUSTOMER SERVICE ON (B)(6) 2017, THAT SHE HAD LOW SUCTION ON HER PUMP IN STYLE BREAST PUMP. THE CUSTOMER ALSO STATED THAT HAS MASTITIS AND WAS PRESCRIBED CLINDAMYCIN BY HER DOCTOR.

  Patient problems: Bacterial Infection

  MAUDE report 6523579 ↗
• InjuryMar 16, 2017Device Operates Differently Than Expected

  ON (B)(6) 2017, THE CUSTOMER REPORTED TO A MEDELA CUSTOMER SERVICE REPRESENTATIVE THAT THE LET DOWN BUTTON WAS NOT WORKING PROPERLY ON HER PUMP IN STYLE BREAST PUMP. AT THAT TIME SHE ALSO REPORTED THAT ON (B)(6) 2017, SHE WAS SEEN BY HER PHYSICIAN AND HAD BEEN PRESCRIBED DOXYCILLIN AND WAS SEEN AGAIN ON (B)(6) 2017, AND PRESCRIBED KFLEX FOR A YEAST INFECTION.

  Patient problems: Fungal Infection

  MAUDE report 6411650 ↗
• InjuryMar 2, 2017Device Operates Differently Than Expected

  THE CUSTOMER REPORTED ON (B)(6) 2017 THAT IS SOUNDS LIKE HER PUMP IN STYLE SKIPS IN BOTH PHASES. SHE ALSO INDICATED THAT SHE HAD MASTITIS 1 1/2 MONTHS AGO AND HER DOCTOR PRESCRIBED HER ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 6372224 ↗
• InjuryJan 23, 2017Decrease in Suction

  ON (B)(6) 2016 THE CUSTOMER REPORTED TO A MEDELA CUSTOMER SERVICE REPRESENTATIVE THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE BREAST PUMP AND THAT SHE HAD BEEN EXPERIENCING ENGORGEMENT, FEVERS, AND THAT SHE HAD BEEN PRESCRIBED ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 6271067 ↗

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