Recall Z-0663-2017 ยท MJN Catheter, Intravascular Occluding, Temporary
Spectranetics Corporation
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.
| Date | Nov 28, 2016 (initiated Oct 31, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging |
| Action | Spectranectics sent an Urgent Medical Device Recall letter dated October 31, 2016, to all affected consignees. Consignees were instructed to discontinue use of the potentially impacted lots and return the product for replacement. Consignees were also instructed to complete the attached Acknowledgement and Receipt Form to facilitate the product return of any remaining product in inventory. Customers with questions were instructed to call 1-800-231-0978, Option 2. For questions regarding this recall call 719-651-8517. |
| Quantity | 873 units |
| Distribution | 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, Ku |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140775 | TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM Spectranetics Corporation, Jul 23, 2014 |