Recall Z-2769-2020 ยท FCG Biopsy Needle
Covidien Llc
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.
| Date | Aug 5, 2020 (initiated Jun 26, 2020) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 | 269 units |
| Distribution | world wide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180037 | Beacon EUS Access System Covidien, LLC, Apr 26, 2018 |