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TGA Suspends Corpuls 3 and 3T After Widespread Failure Reports

The move raises fresh questions about device reliability and the regulator’s transparency.

Overview

  • The Therapeutic Goods Administration announced a suspension of the corpuls 3 and 3T late last month and is set to prevent new sales from about August 25 while it reviews the products.
  • NSW Ambulance and state ministers say units already in service are safe after supplier inspections, hardware remediation and upgrades, and that devices continue to meet operational needs.
  • Internal NSW Ambulance records show about 1,229 recorded corpuls failures in 2025 across roughly 1,500 devices, and analysis of TGA reports found dozens of adverse events since 2022 including injuries, deaths and instances the device refused to shock.
  • Paramedics and unions report continuing faults with capnography (CO2) monitoring, repeated alarms, reconnection problems caused by the monitor/defibrillator module design, overheating and occasional failure to deliver shocks.
  • The controversy puts a $55 million statewide procurement and frontline patient safety under scrutiny, with unions and MPs demanding the TGA and the manufacturer disclose the full reasons for the suspension and detail any patient-risk findings.