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FDAnews Device Daily Bulletin

Philips Spectranetics Recalls Bridge Occlusion Balloon

Sept. 6, 2017

Philips subsidiary Spectranetics recalled its Bridge occlusion balloon after receiving reports of blocked guidewire lumens. The device is used to temporarily block the superior vena cava for emergency control of hemorrhage.

The company said the blocked lumens can be identified by attempting to fully pass the guidewire through the lumen before the procedure. The issue is believed to be linked to a third-party supplier, the company said.

Philips recently closed a $2.2 billion deal to acquire Spectranetics, consolidating it into its image-guided therapy business.

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