St. Jude recalls heart | 合法醫療器材資訊網

St. Jude Medical ($STJ) is recalling the device it uses to deploy its Amplatzer PFO Occluder into the heart, warning that the tech can break and put patients at risk.

The FDA has assigned its most-serious Class I tag to the recall, saying that in a small number of cases, the distal end of the devices core wire can fracture, possibly leading to severe adverse events including death. St. Jude informed customers of the recall in mid-January, the FDA says, and the company is in the midst of dispatching sales associates to replace the devices.

So far, no injuries have been reported, a St. Jude spokeswoman told Bloomberg, and doctors can safely use an older version of the delivery device i...