Reported Aug 2, 2017 · Terminated
Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only)…
Atrium Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Atrium Medical Corporation · 5 Wentworth Dr · Hudson, NH · 03051-4929
Is this the product you have?
5 of 5 products
| Model / number | Product as published |
|---|---|
| — | Atrium iCAST Balloon Expandable Covered Stent |
| — | 7mm x 22mm x 120cm |
85455 | Model/ (Marketed in U.S. only) Atrium Advanta V12 Balloon Expandable Covered Stent |
| — | 7mm x 22mm x 120cm |
85355 | Model/ (Marketed OUTSIDE U.S. only) The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms. |
- Lot codes and dates
- Part Number 85455
Lots 240735240523
- Part Number 85355Lot 240734
- Part Number 85455
- Amount recalled
- 246 (US: 183 units; Foreign: 63 units)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Atrium Medical Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.