Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The JETSTREAM is a rotational atherectomy catheter system designed for Recalled by Boston Scientific Corporation Due to Mislabeling
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 Boston Scientific Corporation directly.
Affected Products
The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The System includes multiple distal ports located at the catheter tip, which are designed to provide independent infusion and aspiration functions for the active removal of fluid, excised tissue and thrombus from the peripheral treatment site.
Quantity: 137
Why Was This Recalled?
Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm Atherectomy Catheters due to these units being mislabeled. Some 1.85mm JETSTREAM SC catheters may have been labeled as 2.1mm catheters, and some 2.1mm JETSTREAM XC catheters may have been labeled as 1.85mm catheters.
Where Was This Sold?
This product was distributed to 24 states: AL, AZ, CT, FL, HI, IL, IN, IA, KY, LA, ME, MI, MO, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report