Spectranetics Corporation recalls Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Len…

Recall date

August 7, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3106-2017

FDA classification

Class I

Brand / firm

Spectranetics Corporation

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Poland, South Africa, Sweden, Switzerland, and United Kingdom.

Why it was recalled

Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.