Z-3106-2017 Class I Terminated
FDA device recall Z-3106-2017 was initiated by Spectranetics Corporation on August 7, 2017 and is designated Class I. Reason for recall: Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment. The recall status is terminated (terminated April 14, 2020). Affected quantity: 2,356 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 4, 2017
- Initiation Date
- August 7, 2017
- Termination Date
- April 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,356 units
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.
Distribution Pattern
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.
Code Information
Model Number 590-001, Lots FMN17B13A, FMN17C08A, FMN17C28A, FMN17D07A, FMN47D12A, FMN17D19A, FMN17D27A, FMN17E02A, FMN17E23A, FMN17E31A, FMN17E31B, FMN17F06A, FMN17F20A, FMN17F21A, FMN17G12A, FMN17G18A. Additional lots: FMN17H03A, FMN17H04A, FMN17H05A, FMN17H10A, FMN17H12A, FMN17H15A, FMN17H17A, FMN17H29A, FMN17J28A, FMN17K02A.