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Pharmaceuticals / Medical Devices / Postmarket Safety

Recall Issued for Spectranetics Bridge Catheter

Sept. 28, 2017
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Spectranetics issued a recall for its Bridge catheter for possible inability to pass the guidewire through the device, resulting in a potential delay of treatment. The FDA determined the cause to be a nonconforming material/component.

The device is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.

Spectranetics mailed a recall letter to customers on Aug. 8, and an updated letter on Aug. 23.

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