Z-2769-2020Class II

Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device...

Name: Z-2769-2020 Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device...
Creator: Covidien Llc
Published: 2020-06-26
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-06-26 / Open, Classified

FDA source

Covidien Llc began a recall of Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge... on 2020-06-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2769-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-06-26
Posted: 2020-08-05
Recalling firm: Medtronic, Inc.
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.
Product code: FCG Biopsy Needle
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 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 in commerce: 269 units
Distribution: world wide distribution
Product codes and lots: Model # DSA-135-01 UDI: 10884521663527 Lot #: F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, F2513453X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2769-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2768-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-12	2020-08-05
Z-2769-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-12	2020-08-05

Product code FCG

K180037Class IIBeacon EUS Access SystemCovidien, LLC / cleared 2018-04-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)