Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Spectranetics Bridge Occlusion Balloon catheter Recalled by Spectranetics Corporation Due to Possible inability to pass the guidewire through the...
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
Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.
Quantity: 2,356 units
Why Was This Recalled?
Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.
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