Covidien Llc: Medical Device Recall in 2020 - (Recall #: Z-2769-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 26, 2020

Date Posted: August 12, 2020

Recall Number: Z-2769-2020

Event ID: 86001

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.

Status: Ongoing

Product Quantity: 269 units

Code Information:

Model # DSA-135-01 UDI: 10884521663527 Lot #: F2510371X, F2510861X, F2512341X, F2512383X, F2512493X, F2513453X

Distribution Pattern:

world wide distribution

Voluntary or Mandated:

Voluntary: Firm initiated