# FDA recall Z-2769-2020

> **Covidien Llc** · Class II · device recall initiated 2020-06-26.

## 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.

## 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.

## Distribution

world wide distribution

## Key facts

- **Recall number:** Z-2769-2020
- **Recalling firm:** Covidien Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-06-26
- **Report date:** 2020-08-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2769-2020

## Citation

> AI Analytics. FDA recall Z-2769-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2769-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*