PlainRecalls
FDA Devices Critical Class I Terminated

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 emer

Reported: October 4, 2017 Initiated: August 7, 2017 #Z-3106-2017

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Spectranetics Corporation
Units Affected
2,356 units
Distribution
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.
Location
Colorado Springs, CO

Frequently Asked Questions

What product 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.. Recalled by Spectranetics Corporation. Units affected: 2,356 units.
Why was this product recalled? ▼
Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 4, 2017. Severity: Critical. Recall number: Z-3106-2017.

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