Boston Scientific Corporation recalls Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monor…

Recall date

October 24, 2019

Source

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

Recall number

Z-0580-2020

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.

Why it was recalled

Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

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

What was recalled

Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.