Marlborough, Mass.-based Boston Scientific, which issued a voluntary recall from its international location in France, said the removal comes in response to an increase in complaints of the RX tunnel component (black sheath) detaching from the catheter shaft.
An investigation by the company has uncovered that the issue is due to a lower bond strength of the tunnel component, which may lead to detachment and potential consequences including prolonged procedure duration while the device is exchanged. That could lead to the most severe potential injury, which is hemorrhage and/or tissue damage/perforation to the common bile duct during the retrieval of a detached RX tunnel component.
Currently, there have been no incidents of patient harm reported related to this issue, which includes no other Boston Scientific product, according to the recall letter.
Users of the affected products are instructed to immediately discontinue use and remove all affected units from their inventory, regardless of where they are stored, then segregate the units in a secure place before returning them to Boston Scientific.
A previous version of this story incorrectly referred to the voluntary recall as a warning letter. This has been updated.