Boston Scientific (NYSE:BSX) is voluntarily recalling certain dilation and extension catheters after finding that specific batches may have missed the hydrophilic coating step in the manufacturing process.
That step is supposed to create a lubricious surface on the devices. Use of a catheter affected by the missed step could boost friction during delivery and withdrawal, delaying a procedure to exchange the device for another, the company said in an urgent field safety notice.
Using the affected catheters could cause vessel trauma, but Boston Scientific said there haven’t been reports of patient injury associated with the missing coating. The company said there is no follow-up needed for patients who have been treated with the affected devices.
The recalled catheters include versions of the Emerge PTCA dilation catheter, NC Emerge Monorail PTCA dilation catheter, Guidezilla II guide extension catheter and Agent paclitaxel-coated PTCA balloon catheter.
The company instructed device users to immediately discontinue use and to notify other healthcare professionals in their organizations about the recall.
Shares of BSX were up 0.4% at $41.87 per share in midday trading today.