Beacon EUS Access System Preloaded Access 90degree 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 loca
Check against the official notice below — it lists the full affected range.
Covidien LLC has voluntarily recalled the Beacon EUS Access System Preloaded Access 90-degree Needle, a sterile, single-use endoscopic ultrasound device, following three customer reports that the device's cannula detached during procedures. In one case, the detached cannula was not retrieved during the procedure. The potential risks associated with cannula detachment include delay in treatment, biliary leak, pain, and retained device fragments.
The recall affects 375 units of Model DSA-090-01 with specific lot numbers (F2510370X, F2510900X, F2512340X, F2512378X, F2512492X, F2512620X, and F2513452X) that were distributed worldwide. The source document does not specify what actions affected consumers should take.
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: 375 units Lot/code info: Model # DSA-090-01 UDI: 10884521722583 Lot #: F2510370X, F2510900X, F2512340X, F2512378X, F2512492X, F2512620X, F2513452X
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.