Boston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects
Boston Scientific is recalling 1,442 Direxion Torqueable Microcatheters worldwide 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II due to manufacturing defects in the hydrophilic coating and nitinol sleeves. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Boston Scientific Cork, Ltd. is recalling 1,442 units of the Direxion Torqueable Microcatheter, model NGMC/FATHOM/021/BERN/2RO/130. The recall covers products distributed worldwide, including the United States, Puerto Rico, and numerous international markets.
The FDA classified this as a Class II recall because the product is defective due to insufficient UV curing of the hydrophilic coating on the outer surface of the distal segment and raised ridges on nitinol sleeves caused by laser cutting misalignment. These defects may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
Healthcare providers and facilities should stop using the affected microcatheters and contact Boston Scientific for instructions on return or replacement. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130; Material Number: M001195670
- Manufacturer
- Boston Scientific Cork, Ltd.
- Affected units
- 1,442
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: M001195670
- UDI-DI: 08714729839668
- Batch Numbers: 37881100
- 37889829
- 37914477
- 37914478
- 37914479
- 37943144
- 37981351
- 37981352
- 38002448
- 38002449
- 38002450
- 38017051
- 38017052
- 38022674
- 38022676
- 38073300
- 38073301
- 38273216
Distribution
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