> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Spectranetics Recalls Bridge Occlusion Balloon
- URL: https://www.fdaweb.com/spectranetics-recalls-bridge-occlusion-balloon/
- Published: 2017-08-31T12:00:00.000Z
- Updated: 2026-09-14T22:45:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139525

Spectranetics has recalled its Bridge Occlusion Balloon due to the potential for a blocked guidewire lumen. The device is indicated for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. To date, Spectranetics has received nine customer complaints, none of which has resulted in any serious injury to the patient, according to a [recall notice](http://www.bfarm.de/SharedDocs/Kundeninfos/EN/07/2017/08495-17%5Fkundeninfo%5Fen.pdf;jsessionid=A58A97136DAB1C2724FA2B93AD533A79.2%5Fcid354?%5F%5Fblob=publicationFile&v=1&ref=fdaweb.com). “Based on inspection, the frequency of a potentially blocked guidewire lumen is estimated to be approximately 10%,” it says. “Additional investigations are required prior to implementing a fix.”