Recall Z-0663-2017
Spectranetics Corporation · initiated October 31, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: FMN16E11A; FMN16E18A; FMN16E25A; FMN16F01A; FMN16F08A; FMN16F15A FMN16F22A; FMN16G13A; FMN16G19A; FMN16G25A; FMN16H04A; FMN16H23A; FMN16J27A
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.
FDA-determined cause: Packaging
Action taken
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.
Details
- Recall number
- Z-0663-2017
- Initiated
- October 31, 2016
- Posted by FDA
- November 28, 2016
- Terminated
- April 18, 2017
- Product code
- MJN – Catheter, Intravascular Occluding, Temporary
- 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, Kuwait, Taiwan, Thailand.
- Recalling firm
- Spectranetics Corporation, Colorado Springs, CO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0661-2017 Class II | Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152…Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA… | 10/31/2016Terminated |
| Z-0662-2017 Class II | ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016…Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA… | 10/31/2016Terminated |