medical Class II Updated 2019-12-04

Boston Scientific Corporation recalls Rebel Monorail PtCr Coronary Stent System, REF / Catalog No.

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot / GTIN Number / Use By: 24077337 / 8714729843443 / 2019-07-17.
View official government recall

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