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

Recalled October 4, 2017 · FDA recall Z-3106-2017 · Spectranetics

Hazard

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

Units

2,356 units

Sold at

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.

Description

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

Product

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.

Manufacturer(s)

Spectranetics Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →