Boston Scientific product recalled over labeling errors

Recall date

April 5, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Boston Scientific Corporation recalls The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease i…

Recall number

Z-1922-2017

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

US: AL, AZ, CT, FL, HI, IL IN, IA, KY, LA, ME, MI, MO, NJ,NY, OH, OR, PA, SC, TN, TX, VA, WA, WI. OUS; GERMANY, GREAT BRITAIN, POLAND, NETHERLANDS

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.