Boston Scientific Recalls Direxion Torqueable Microcatheters for Coating Defects
Boston Scientific is recalling 1,349 Direxion Torqueable Microcatheters due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.
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 Class II, and the source describes manufacturing defects involving insufficient UV curing and laser cutting misalignment. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Boston Scientific Cork, Ltd. is recalling 1,349 units of the Direxion Torqueable Microcatheter, Material Number M001195500. The recall covers specific batch numbers distributed worldwide, including the United States, Puerto Rico, and numerous international markets.
The product is defective due to insufficient UV curing of the hydrophilic coating on the outer surface of the distal segment of the microcatheters. Additionally, the devices have raised ridges on nitinol sleeves caused by laser cutting misalignment.
The source text does not report any illnesses, injuries, or deaths associated with this recall. The source does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices.
The recalled product
- Product
- Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130; Material Number: M001195500
- Manufacturer
- Boston Scientific Cork, Ltd.
- Affected units
- 1,349
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 (20)
- Material Number: M001195500
- UDI-DI: 08714729839576
- Batch Numbers: 38061298
- 38061299
- 38092411
- 38092412
- 38092413
- 38112475
- 38112476
- 38112477
- 38167702
- 38167705
- 38181964
- 38181965
- 38181966
- 38181967
- 38181968
- 38416361
- 38416362
- 38595650
Distribution
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