Boston Scientific Cork recalls Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130
FDAHome & Health recallNo official product photo was published for this recall.
What should I do?
Check whether you have this device (see the product and lot details below). If you do, stop using it and contact the company or your healthcare provider for next steps.
What's the hazard?
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
What's affected
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130; Material Number: M001195340