Vital Signs™ 7000AAORecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10190752142176), received between Apr 1, 2022 and May 4, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 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, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Mechanical Problem

  IT WAS REPORTED THAT THE FETAL SCALP ELECTRODES ARE DIFFICULT TO DEPLOY DURING INSERTION DUE TO THE SLEEVE BECOMING STUCK, RESULTING IN DEVICE DISCARD AND THE NEED TO USE AN ADDITIONAL ELECTRODE. NO HARM WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068688 ↗
• MalfunctionNov 27, 2024Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem

  IT WAS REPORTED THAT "SPIRAL FETAL ELECTRODE BEING LEFT INSIDE A PATIENT FOLLOWING DELIVERY. IT (PART OF FSE) WAS LEFT INSIDE THE MOTHER FOLLOWING A C SECTION DELIVERY, IT WAS DISCONNECTED FROM THE BABY, THE BABY WAS OK AND WAS DELIVERED. IT HAPPENED DURING A SWAB', THE PART OF THE FSE WAS SHIFTED AND PUSHED FURTHER UP INTO THE MUM. THEY HAD DISCONNECTED THE FSE FROM THE BABY, HAD CUT THE WIRE AND THAT PART WAS LEFT INSIDE THE MUM".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20793826 ↗
• MalfunctionJan 14, 2024Disconnection; Disconnection

  THE CUSTOMER REPORTED THAT THE LEG ATTACHMENT PAD WOULD NOT STAY CONNECTED TO THE CABLE. THE NURSE WILL PUSH DOWN AND PINCH IT, AND IT WILL TRANSMIT PROPERLY, BUT WHEN THEY LET GO, IT CREATES AN ARTIFACT, AND THE FETAL HEART RATE CANNOT BE TRACED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509777 ↗
• MalfunctionDec 19, 2023Fitting Problem; Connection Problem; Fitting Problem; Connection Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT WHEN THE PROVIDER WAS ATTEMPTING TO PLACE A FETAL SCALP ELECTRODE ON A TRIAL OF LABOR AFTER A CESAREAN (TOLAC) PATIENT WHO WAS LABORING NATURALLY WITHOUT AN EPIDURAL, THE 7000AAO-ELECTRODES, FETAL SCALP (FSE), 50/CASE WOULD NOT STAY SNAPPED INTO PLACE OR STUCK TO THE PATIENT'S LEG AND THEREFORE WOULD NOT READ. A REGISTERED NURSE (RN) AT THE DESK RETRIEVED ANOTHER FETAL SCALP ELECTRODE (FSE) AND CORD FROM ANOTHER ROOM THAT WAS PLACED WITHOUT INCIDENT. THE PATIENT'S CURRENT STATUS IS STILL UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361329 ↗
• MalfunctionOct 12, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THEY ARE ATTEMPTING TO PLACE FETAL SPIRAL ELECTRODE FOR COROMETRICS ON A TOLAC (TRIAL OF LABOR AFTER CESAREAN DELIVERY) PATIENT WHO WAS LABORING NATURALLY AND THE PRODUCT WOULD NOT STAY SNAPPED INTO PLACE NOR WOULD IT STICK YO THE PATIENT'S LEG. FURTHERMORE, THE CUSTOMER CONFIRMED NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927783 ↗
• InjuryJan 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THAT THE FETAL SPIRAL ELECTRODE FOR COROMETRICS SHOWS INCORRECT READINGS DURING PATIENT USE.AN ALTERNATIVE DEVICE WAS USED AS AN INTERVENTION. FURTHERMORE, THE CUSTOMER CONFIRMED NO HARM DONE TO THE NEWBORN BABY AND MOTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16092210 ↗
• InjuryApr 1, 2022Defective Component; Defective Component

  THE CUSTOMER REPORTED THAT THE FETAL SPIRAL ELECTRODE FOR COROMETRICS DID NOT PICK UP FETAL HEART RATE WHEN APPLIED BY PHYSICIAN DURING LABOR AND DELIVERY. FURTHERMORE, THE CUSTOMER CONFIRMED THAT THE NEWBORN BABY WAS POKED FOUR TIMES TO OBTAIN A TRACING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13982901 ↗
• InjuryApr 1, 2022Defective Component; Defective Component

  THE CUSTOMER REPORTED THAT THE FETAL SPIRAL ELECTRODE FOR COROMETRICS DID NOT PICK UP FETAL HEART RATE WHEN APPLIED BY PHYSICIAN DURING LABOR AND DELIVERY. FURTHERMORE, THE CUSTOMER CONFIRMED THAT THE NEWBORN BABY WAS POKED SIX TIMES TO OBTAIN A TRACING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13981284 ↗