Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including
FDA device recall Z-0663-2017 · posted 2016-11-28 · Terminated
Recall details
- Recalling firm
- Spectranetics Corporation
- 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.
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- MJN
- Quantity affected
- 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 K
- Date initiated
- 2016-10-31
- Date posted
- 2016-11-28
- Date terminated
- 2017-04-18
- Location
- Colorado Springs, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM (K140775) | Spectranetics Corporation | 2014-07-23 |