Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Volcano PV .035 Catheter: Part number: 88901 Recalled by Volcano Corporation Due to During a relabeling procedure at the manufacturing facility,...
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 PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.
Quantity: 162 total devices (included both products)
Why Was This Recalled?
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
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