Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the Recalled by Spectranetics Corporation Due to Spectranetics Corporation announces a voluntary field action for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Spectranetics Corporation directly.
Affected Products
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.
Quantity: 873 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Spectranetics Corporation
Spectranetics Corporation has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report