Recall Z-0663-2017— Spectranetics Corporation
Class II · Terminated
Class II FDA medical device recall by Spectranetics Corporation, initiated 2016-10-31, terminated 2017-04-18. It names one FDA 510(k) clearance: K140775. 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.. 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..
- Recalling firm
- Spectranetics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-31
- Terminated
- 2017-04-18
- Firm location
- Colorado Springs, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.