Drug recall
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia…
FDA recall event 66322 · Class II · Medtronic Vascular, Inc.
Key facts
| Event ID | 66322 |
|---|---|
| Recall numbers | Z-0083-2014 |
| Recalling firm | Medtronic Vascular, Inc. |
| Product type | Devices |
| Products | Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU. |
| Initiation date | Sep 19, 2012 |
| Report date | Nov 6, 2013 |
| Termination date | Oct 25, 2013 |
| City | Santa Rosa |
| State | CA |
| Country | United States |
| FEI number | 3005364322 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: