Drug recall
Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930…
FDA recall event 81924 · Class II · Edwards Lifesciences, LLC
Key facts
| Event ID | 81924 |
|---|---|
| Recall numbers | Z-0835-2019 |
| Recalling firm | Edwards Lifesciences, LLC |
| Product type | Devices |
| Products | Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures. |
| Initiation date | Jan 22, 2019 |
| Report date | Feb 20, 2019 |
| Termination date | Mar 26, 2019 |
| City | Draper |
| State | UT |
| Country | United States |
| FEI number | 1713910 |
At a glance
- 1–9 Products in this recall
- 10–99 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: