Baby deaths associated with home-use foetal heart monitors

TGA (Australia)

SAFETY ALERT

Published: 8/13/2025Detected: 3/25/2026

Summary preview

Safety alert warning that home-use foetal heart monitors can provide false reassurance, potentially delaying appropriate clinical evaluation of infants and contributing to fatal outcomes.

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#foetal heart monitor

#home use device

#misleading reassurance

#patient labeling

#post-market surveillance

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