Atrium iCAST Balloon Expandable Covered Stent — Class II medical device recall Z-2761-2017
Terminated recall by Atrium Medical Corporation, reported 2017-08-02, distributed nationwide. Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v1
| Recall number | Z-2761-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Hudson, NH, United States |
| Recall initiated | 2017-05-25 |
| Classified | 2017-07-25 |
| Reported by FDA | 2017-08-02 |
| Terminated | 2020-06-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, DE, FR, GB, IE, IT, NL, SE |
| Lot numbers | 240523, 240734, 240735 |
| Model numbers | 240523, 240735, 85355, 85455 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2761-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.