Boston Scientific Recalls Rebel Monorail Coronary Stent Systems
Boston Scientific is recalling 14,145 Rebel Monorail PtCr Coronary Stent Systems because they may be missing a hydrophilic coating step.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a manufacturing defect (missing coating) creates a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Boston Scientific Corporation is recalling 14,145 units of the Rebel Monorail PtCr Coronary Stent System, specifically the 3.0mm x 24mm size (REF / Catalog No. H7493927324300). The affected devices are balloon expandable Platinum Chromium (PtCr) Alloy stents pre-mounted on a Monorail Catheter.
The recall was initiated because certain dilation and extension catheters may have missed the hydrophilic coating step during the manufacturing process. This coating is intended to create a lubricious surface on the devices. The affected lot number is 24077337, with a GTIN of 8714729843443 and a use-by date of July 17, 2019.
The devices were distributed nationwide, including Washington D.C. and Puerto Rico, as well as to Canada. Healthcare providers and facilities should stop using these specific devices and contact Boston Scientific for further instructions.
The recalled product
- 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.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 14,145
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot / GTIN Number / Use By: 24077337 / 8714729843443 / 2019-07-17.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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