Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Volcano TrakBack II Disposable Pullback Device Recalled by Volcano Corporation Due to Internal testing had identified a potential breach to...
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 Volcano Corporation directly.
Affected Products
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
Quantity: 8251 total devices (3777 US)
Why Was This Recalled?
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Volcano Corporation
Volcano Corporation has 22 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report