SOS FP-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05060388740009), received between Aug 23, 2023 and Aug 3, 2026 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the Australian TAG that during a complicated birth, obstructed labour and fetal distress requiring manual fetal head disimpaction for planned emergency LUSCS, first attempted Fetal Pillow device and babe was born flat and suffered suspected subgaleal haemorrhage. Fetal pillow device recommended maximum inflation is 180cc and device found to have been inflated to 250cc. Baby required initial resuscitation and Special Care Nursery for observation, subsequently baby discharged home. Unknown long term effects.1216677-2026-00076 FP-010 Fetal Pillow 2026-07-0000460.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50117579 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT CESAREAN DELIVERY FOR ARREST OF DESCENT. A FETAL PILLOW WAS FELT TO HAVE BEEN PROPERLY USED ACCORDING TO MANUFACTURER'S INSTRUCTIONS. NEWBORN WAS NOTED AT BIRTH TO HAVE A DEPRESSED SKULL FRACTURE WITH A SHAPE OF THE INDENTATION THAT COULD HAVE REFLECTED PRESSURE FROM THE FETAL PILLOW. IT COULD NOT BE DETERMINED WHETHER THE FRACTURE RESULTED FROM PRESSURE FROM THE FETAL PILLOW, FROM THE FORCES OF LABOR, OR FROM THE OPERATOR'S HAND THAT WAS USED TO ELEVATE THE HEAD FROM THE MATERNAL PELVIS AND THROUGH THE HYSTEROTOMY. 1216677-2026-00031 FP-010 FETAL PILLOW (B)(4).

  Patient problems: Skull Fracture

  MAUDE report 24872896 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CAESAREAN DELIVERY, THE BABY WAS OP (OCCIPUT POSTERIOR) PRESENTATION. THE DOCTOR WAS USING THE FETAL PILLOW FOR THE FIRST TIME; AND HE FOUND THE PILLOW WORKED WELL WITH A RESULTING SUCCESSFUL DELIVERY. IT WAS FOUND 2 TO 3 HOURS LATER THAT THE PATIENT WAS HEMORRHAGING. THE PATIENT WAS TAKEN BACK TO OR AND TWO LACERATIONS WERE NOTICED BEHIND THE UTERUS. THE PATIENT HAD TWO LACERATIONS NOTED SYMMETRICALLY ON THE POSTERIOR ASPECT OF THE BROAD LIGAMENT; THESE WERE ACTIVELY BLEEDING CAUSING THE HEMORRHAGE. THE PROVIDERS ARE CONCERNED THAT THIS MAY HAVE BEEN CAUSED BY THE FETAL PILLOW. POSSIBLY TEARS FROM STRETCHING. BLOOD TRANSFUSION WAS NEEDED DUE TO THE BLOOD LOSS. PATIENT ADMITTED TO THE ICU WITH SIX DAYS ADMITTANCE FOR RECOVERY. NO ADDITIONAL INFORMATION. FP-010 FETAL PILLOW 2025-11-0000507.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 23698188 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED FROM A CASE STUDY THAT AFTER AN UNCOMPLICATED PREGNANCY, A MALE BABY WAS DELIVERED BY EMERGENCY CAESAREAN SECTION AT 39 WEEKS OF GESTATION. BIRTH WAS COMPLICATED BY OBSTRUCTED LABOR, OCCIPUT POSTERIOR FETAL POSITION AND PROLONGED FETAL BRADYCARDIA. THE FETAL HEAD WAS IMPACTED AND, DESPITE THE USE OF FETAL PILLOW, THE HEAD WAS DIFFICULT TO EXTRACT FROM THE PELVIS. NEITHER FORCEPS NOR VACUUM DEVICES WERE USED TO FACILITATE DELIVERY. AT BIRTH, THE BABY WAS APNEIC, PALE AND BRADYCARDIC. THE BABY WAS INTUBATED AND HAD CHEST EXPANSION. CARDIAC COMPRESSIONS WERE ADMINISTERED AND THE BABY RECEIVED INTRAVENOUS ADRENALINE. SPONTANEOUS RESPIRATIONS AND CARDIAC OUTPUT WERE ESTABLISHED AT 10 MIN OF LIFE. THE BABY WAS ADMITTED TO THE NEONATAL INTENSIVE CARE UNIT FOR ONGOING CARE AND FOR THERAPEUTIC HYPOTHERMIA. TRUNCAL PETECHIAE WAS NOTICED AT 20 MINUTES OF AGE AND COAGULATION STUDIES WERE FOUND TO BE ABNORMAL. NO ADDITIONAL INFORMATION IS AVAILABLE. FP-010 FETAL PILLOW (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201874 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17802733 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17802585 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17605773 ↗