FDA classifies St. Jude Medical's notice on device as Class I recall

08/15/2010 | MedPage Today (free registration)

St. Jude Medical has released a notice about the recall of several lots of its 6 French Engage Introducer devices, which are used to deliver catheters and electrodes into blood vessels, because the device's shaft or hub assembly has the potential to fracture and could result in fatal hemorrhage. The company's move has been classified by the FDA as a Class I recall.

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