Steerable sheaths for PFA recalled due to safety risk
Boston Scientific has recalled more than 750,000 steerable sheaths used during pulsed field ablation (PFA) procedures. This recall only applies to specific lots of these steerable sheaths; no PFA catheters or other related devices are included.
The U.S. Food and Drug Administration (FDA) has classified this as a Class II recall. This means using the device without following the manufacturer’s recommendations could lead to “temporary or medically reversible adverse health consequences.”
No steerable sheaths need to be returned to the manufacturer. However, there are specific instructions clinicians should follow going forward.
Which devices are part of this Class II recall?
The 13 French Faradrive Steerable Sheath was designed to work with Boston Scientific’s Farawave and Farawave NAV PFA catheters. It is 91 cm long with a usable length of 74 cm.
In total, this recall includes approximately 776,000 steerable sheaths. Some of them were originally distributed to be part of an investigational device exception clinical trial conducted by Boston Scientific. Lot information is available here, here, here and here.
Image courtesy of Boston Scientific.
Why were the devices recalled?
Multiple customers have complained about hemostatic valve damage caused by how the dilator was oriented during device preparation.
“Valve damage may result in air ingress, potential air embolism and associated patient harm,” according to Boston Scientific. “This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.”
What should customers do?
The devices do not need to be returned, customers have been told to follow the updated instructions for use going forward to avoid any issues.
“Forward this notice to relevant personnel and any facilities to which the product was transferred,” Boston Scientific added in its recall notice.
Click here for additional details from the FDA.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.