American pacemakers returned
23 August 2007
China has returned 272 imported pacemakers from the US after they failed quality tests, state media reported. The General Administration of Quality Supervision, Inspection and Quarantine said that the devices, worth a total of US$240,000, were impounded in Shanghai at the end of April. The administration said that the devices' pulse strength, when tested, did not match their indicated properties and could potentially cause a misdiagnosis and threaten a user's life. The devices were made by St Jude Medical, a firm that had been investigated by the State Food and Drug Administration (SFDA) in 2001. The SFDA is in the midst of a six-month-long campaign to increase inspections on imported drugs and medical devices following the death of a Shanghai teenager that was allegedly caused by an unregistered imported heart pump.
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