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 locations of the gastrointestinal tract.
FDA Recall Z-2768-2020 · Posted 2020-08-05
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Recalling FirmCovidien Llc
Recall StatusOpen, Classified
Product CodeFCG
Date Initiated2020-06-26
Product Quantity375 units
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.
Firm Action
Medtronic sent a letter notification to customers dated July 06, 2020 recalling effected lots of product. This letter instructed customers to discontinue use of the product and quarantine effected inventory. Customers were also instructed to return effected product and complete recall response forms accordingly.
Root Cause
Under Investigation by firm
Distribution Pattern
world wide distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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