Covidien recalls Beacon EUS Access System Preloaded Access 135-degree needle for potential cannula detachment during procedures, risking delayed treatment, biliary leaks, or retained fragments.
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.
Covidien is recalling a specific endoscopic ultrasound device due to reports of the cannula detaching during procedures. This could lead to delayed treatment, biliary leaks, or retained device fragments if the cannula isn't retrieved.
The cannula can detach during procedures, potentially causing delays in treatment, biliary leaks, pain, or retained device fragments if not properly retrieved by the medical team.
Healthcare professionals using the Beacon EUS Access System for endoscopic procedures are most at risk, particularly those handling the recalled model numbers.
Check for model number DSA-135-01 and lot numbers F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, or F2513453X on the device packaging or label.
Verify the model number on the device packaging or label to confirm if it matches DSA-135-01.
Reach out to Covidien for guidance on next steps if the device is part of the recall.
Covidien is recalling the Beacon EUS Access System after three reports of the cannula detaching during procedures, which could cause delayed treatment, biliary leaks, pain, or retained device fragments.
The affected model is DSA-135-01 with lot numbers F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, and F2513453X.
The recall record does not specify a remedy; users should contact Covidien for guidance.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2769-2020 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2769-2020 from Covidien. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
