Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to loc
Check against the official notice below — it lists the full affected range.
Covidien LLC has issued a voluntary recall of 269 units of the Beacon EUS Access System Preloaded Access 135-degree Needle, a sterile, single-use endoscopic ultrasound device. The recall was initiated following three reports from customers of the device's cannula detaching during procedures. In one reported case, the detached cannula was not retrieved during the procedure, creating potential risks including delayed treatment, biliary leak, pain, and retained device fragments. The affected devices have Model Number DSA-135-01 and were distributed worldwide across six specific lot numbers: F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, and F2513453X.
The source record does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.
Reason for recall: This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments. Distribution: world wide distribution Quantity: 269 units Lot/code info: Model # DSA-135-01 UDI: 10884521663527 Lot #: F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, F2513453X
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.