FDA-Device2019-12-04Class II
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.
Boston Scientific Corporation
Hazard
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.
Sold states
Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.
Affected count
14,145 devices total
Manufactured in
1 Scimed Pl, Maple Grove, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0580-2020Don't want to check this manually?
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