A Tokyo importer of medical devices said Saturday it will recall 1,806 pacemaker units made in the United States as there is a possibility they may malfunction.
A total of 16,025 units of six models of pacemaker manufactured by Guidant Corp. of the U.S. have been shipped, but 14,219 have already been implanted into people, Intermedics Japan K.K. said.
As well as recalling all of the unused devices, the company will monitor the conditions of the people fitted with the pacemakers, it said.
Intermedics Japan decided on the recall after a medical institution in Hokkaido informed the company last month that a pacemaker made by Guidant had failed.
According to the company, the medical institution implanted a Pulsar Max II DR unit into a man in his 80s but had to operate again to replace the pacemaker because it did not work.
Intermedics Japan sent the pacemaker to Guidant, which found that integrated circuits were improperly attached to the circuit board inside the device.
The Japanese importer said it decided to recall all pacemaker models it imported from the U.S. manufacturer to ensure safety. The pacemakers were imported between February 2000 and this month.
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