Boston Scientific Recalls NC Emerge Monorail PTCA Catheters for Coating Defect
Boston Scientific is recalling NC Emerge Monorail PTCA Dilatation Catheters because they may be missing a hydrophilic coating step during manufacturing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a manufacturing defect (missing coating) without reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Boston Scientific Corporation is recalling 14,145 units of the NC Emerge Monorail PTCA Dilatation Catheter. The recall affects devices sterilized using ethylene oxide and packaged in various sizes, including 3.50mm x 8mm and 4.00mm x 8mm configurations.
The recall was initiated because certain 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 lots were distributed nationwide, including Washington D.C. and Puerto Rico, as well as to Canada.
Healthcare providers and facilities should check their inventory for the specific lot numbers and GTINs listed in the official recall notice. If the devices are found, they should be removed from use and returned to Boston Scientific according to the company's instructions.
The recalled product
- Product
- NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM; 2. REF/Catalog No. H7493927608350, NC EMERGE MR OUS 3.50MM X 8MM; 3. REF/Catalog No.…
- Manufacturer
- Boston Scientific Corporation
- 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)
- 23874443 / 8714729847137 / 2021-05-29
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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