FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Loose Cardioband Anchors Prompt Recall

March 1, 2018

Edwards Lifesciences recalled the anchors used in its Cardioband mitral valve repair device.

The company initiated the recall based on two reports that the device had come loose from the surrounding tissue. The company blamed the problem on a manufacturing change.

The recalled anchors were not implicated in any deaths and they do not pose any risk of embolization as they remained attached to the implant, the company said.

No other components of the device are affected by the recall.

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