Koala® IPC-5000ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814247020178), received between Feb 4, 2021 and Dec 31, 2024 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathDec 31, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REPORTER STATED THE 27.6/7 GESTATION SUSTAIN 10.4 CM. LACERATION ALL THE WAY DOWN TO HER SKULL WHILE SHE IS IN HIS MOTHER'S WOMB. MOM HAD PREMATURE RUPTURE OF MEMBRANES AND ADMITTED TO THE HOSPITAL, AND SHE DEVELOPED CHORIO. THE ATTENDING OB PHYSICIAN ORDERED IUPC, MULTIPLE INSERTION ATTEMPTS BY THE RESIDENT AND A FELLOW FAILED. MOM'S VAGINA WAS COVERED WITH FRANK BLOOD. THE BABY WAS DELIVERED BY CAESAREAN SECTION AT 11:50 PM IN (B)(6) HOSPITAL BY EMERGENCY C-SECTION. THE BABY WAS ADMITTED ON (B)(6) 2022 AND EXPIRED ON (B)(6) 2022. THE AUTOPSY DIAGNOSIS WAS BACTERIAL MENINGITIS. THE BABY WITH SCALPED AT THE TIME OF DELIVERY. THE BABY WAS DELIVERED 2 HOURS LATER, AND THE LACERATION WAS DISCOVERED. THE ULTRASOUND CONFIRMED THE INJURY OCCURRED WHILE BABY IS IN HIS MOTHER'S WOMB.

  Patient problems: Head Injury; Laceration(s)

  MAUDE report 21048361 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN THE CUSTOMERS WORDS: "UTERINE RUPTURE AFTER USING IUPC FOR AMNIOINFUSION. IUPC PLACED AT 0254. AMNIOINFUSION STARTED AT 0905 300 ML BOLUS AT RATE OF 999ML/HR THEN 50 ML/HR. WAS STARTED APPROXIMATELY 90 MINUTES PRIOR TO IDENTIFICATION OF UTERINE RUPTURE. NO FLUID RETURNED FROM AMNIOINFUSION, ABDOMEN PALPATED SOFT BETWEEN CONTRACTIONS. URGENT C/S DUE TO CONCERN FOR UTERINE RUPTURE, EXHIBITED CHANGE IN SVE AND LOSS OF ABILITY TO FIND FHT WITH EXTERNAL AND INTERNAL MONITORS. SURGEON NOTED PLACENTAL FRAGMENTS AND FETAL HEAD PALPABLE EXTRAUTERINE CONSISTENT WITH UTERINE RUPTURE. THERAPY DURATION: 1.5 HOUR. UTERINE ACTIVITY, MEASUREMENT OF MVUS."

  Patient problems: Uterine Perforation

  MAUDE report 19230704 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THE FOLLOWING: "WE HAVE BEEN USING THE IUPC'S FOR A COUPLE WEEKS NOW AND HAVE HAD A COUPLE INJURIES TO BABIES THAT ARE POTENTIALLY RELATED THE TO THE INSERTION OF THE KOALA IUPCS".

  Patient problems: Injury

  MAUDE report 11280027 ↗