Boston Scientific (NYSE:BSX) is recalling select lots of its 9Fr Acuity Pro coronary sinus outer guide catheters due to issues with the proximal handle separating from the shaft of the device.
Boston Scientific named 16 different models in the recall, with 158 different lot numbers indicated.
The recalled Acuity catheters are designed to provide pathways into the coronary venous system for the implantation of left ventricular pacing leads.
The device consists of a proximal handle with an integrated hemostasis valve and shaft with flexible distal segments, the company said. After the lead is placed, the handle and distal segment are cut and removed.
Marlborough, Mass.-based Boston Scientific said it received reports of handle separations during the cut and removal process, but no reports of injury. The company said the “most serious anticipated injury” due to the issue would be prolongation of the lead placement procedure.
Boston Scientific said the issue may stem from off-center placement and bonding of the hub and shaft during manufacturing. The company released specific instructions to return affected devices.
On Wednesday, Boston Scientific initiated a voluntary recall of its Chariot Guiding Sheaths designed to be used during peripheral vascular procedures due to the risk of shaft separation.
The FDA labeled the recall as a Class I, according to Boston Scientific. A Class 1 is the most serious type of recall issued by the federal watchdog, indicating “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
Boston Scientific said it received 14 complaints over shaft separation issues, 4 of which involved separation of the distal shaft, all of which occurred during device preparation or use.
