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.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 14,145 Rebel Monorail PtCr Coronary Stent System devices (Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm) distributed nationwide, including Washington D.C., Puerto Rico, and Canada. The recall affects devices from Lot 24077337 with a use-by date of July 17, 2019. The stent systems are being recalled because certain dilation and extension catheters may have missed a manufacturing step that applies a hydrophilic coating, which creates a lubricious (slippery) surface on the devices.
The absence of this coating could affect the performance of the catheters during use. The source document does not specify a remedy or further action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada. Quantity: 14,145 devices total Lot/code info: Lot / GTIN Number / Use By: 24077337 / 8714729843443 / 2019-07-17.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.