# FDA recall Z-2761-2017

> **Atrium Medical Corporation** · Class II · device recall initiated 2017-05-25.

## Product

Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number  85455 (Marketed in U.S. only)    Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm;  Model/Part Number  85355 (Marketed OUTSIDE U.S. only)      The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.

## Reason for recall

Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x 38 mm x 80 cm. The complaint was the result of incorrect dimensional information (7mm x 38mm x 80cm) printed on the manifiold (catheter hub).  The complaint device physical dimensions matched the dimensional information displayed on the outer packaging and the device inner pouch.  This was the only complaint received for this non-conformance.

## Distribution

Worldwide distribution-US (nationwide) and countries of: Germany, Great Britain, Austria, Ireland, Netherlands, France, Italy, Sweden, and San Marino.

## Key facts

- **Recall number:** Z-2761-2017
- **Recalling firm:** Atrium Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-25
- **Report date:** 2017-08-02
- **Termination date:** 2020-06-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hudson, NH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2761-2017

## Citation

> AI Analytics. FDA recall Z-2761-2017. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-2761-2017. Source: US FDA. Licensed CC0.

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