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U.S. Department of Health and Human Services

Class 2 Device Recall Beacon EUS Access System Preloaded Access 135degree Needle

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  Class 2 Device Recall Beacon EUS Access System Preloaded Access 135degree Needle see related information
Date Initiated by Firm June 26, 2020
Date Posted August 05, 2020
Recall Status1 Open3, Classified
Recall Number Z-2769-2020
Recall Event ID 86001
510(K)Number K180037  
Product Classification Biopsy needle - Product Code FCG
Product 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 locations of the gastrointestinal tract.
Code Information Model # DSA-135-01 UDI: 10884521663527 Lot #: F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, F2513453X
Recalling Firm/
Manufacturer
Covidien Llc
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact
770-662-0510
Manufacturer 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.
FDA Determined
Cause 2
Under Investigation by 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.
Quantity in Commerce 269 units
Distribution world wide distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FCG and Original Applicant = Covidien llc
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