COLORADO SPRINGS, CO — Spectranetics is recalling specific lots of its Bridge Occlusion Balloon Catheter, designed to occlude the superior vena cava for control of hemorrhage during procedures, especially device lead extractions, because their guidewire lumens may be blocked[1].
The FDA is categorizing the recall as class 1.
If one of the affected devices were to be used, it wouldn’t be positioned correctly, “and hemorrhage would not be controlled. This would delay lifesaving treatment, which may result in immediate and serious adverse health consequences, including death,” according to the company.
The affected devices are model number 590-001 in specific lots manufactured between February 13, 2017 and July 18, 2017 and distributed through July 21.
The company says it sent customers a device recall notice on August 7 instructing clinicians to check for an open guidewire lumen before procedures “and to have backup units on hand should they be needed during the procedure.”
“Be aware that all Bridge inventory will continue to have the potential for a guidewire lumen blockage until Spectranetics has implemented a permanent solution,” the company says.
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