Covidien recalls Beacon EUS Access System preloaded 90-degree needles due to reports of cannula detaching during procedures, potentially causing delays, 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 its Beacon EUS Access System preloaded 90-degree needles after three reports of the cannula detaching during procedures. This could lead to treatment delays, biliary leaks, pain, or retained device fragments.
The cannula can detach during procedures, which may not be retrieved. This risks delaying treatment, causing biliary leaks, pain, or leaving device fragments inside the body.
Healthcare professionals using the Beacon EUS Access System for endoscopic ultrasound procedures are most at risk. Patients undergoing these procedures may face complications if the cannula detaches.
Check for the model number DSA-090-01 on the device. The lot numbers F2510370X through F2513452X were produced for this recall.
Look for the model number DSA-090-01 on the device packaging or label.
Reach out to Covidien for guidance on next steps if you have the recalled model.
Covidien recalls the Beacon EUS Access System after three reports of the cannula detaching during procedures, which could cause treatment delays, biliary leaks, pain, or retained device fragments.
The affected model is DSA-090-01 with lot numbers F2510370X through F2513452X.
The recall record does not specify a fix; users are advised to 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-2768-2020 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2768-2020 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.
