Z-0663-2017 Class II Terminated
FDA device recall Z-0663-2017 was initiated by Spectranetics Corporation on Oct 31, 2016 and is designated Class II. Reason for recall: Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised i… The recall status is terminated (terminated Apr 18, 2017). Affected quantity: 873 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 7, 2016
- Initiation Date
- Oct 31, 2016
- Termination Date
- Apr 18, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 873 units
Product Description
Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.
Reason for Recall
Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
Distribution Pattern
Worldwide Distribution - US (nationwide and PR) Internationally to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.
Code Information
FMN16E11A; FMN16E18A; FMN16E25A; FMN16F01A; FMN16F08A; FMN16F15A FMN16F22A; FMN16G13A; FMN16G19A; FMN16G25A; FMN16H04A; FMN16H23A; FMN16J27A