Beacon recallZ-2769-2020 · Covidien Llc · initiated Jun 26, 2020
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2769-2020
- Status
- Open, Classified
- Initiated by the company
- Jun 26, 2020
- Posted by the FDA
- Aug 5, 2020
- Recalling firm
- Covidien Llc
- Quantity
- 269 units
- Product code
- FCG
- FDA submissions
- K180037
- Distribution
- world wide distribution
Product description
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 (models, lots, serial numbers)
Model # DSA-135-01 UDI: 10884521663527 Lot #: F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, F2513453X
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Beacon DSA-135-01Covidien LP · Biopsy Needle1 recall4 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K180037 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Beacon DSA-090-01Covidien LP · Biopsy needle1 recall2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 86001).
- Z-2768-2020 · Open, ClassifiedBeacon 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-shap…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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