Drug recall
Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart…
FDA recall event 67362 · Class II · Edwards Lifesciences, LLC
Key facts
| Event ID | 67362 |
|---|---|
| Recall numbers | Z-0918-2014 |
| Recalling firm | Edwards Lifesciences, LLC |
| Product type | Devices |
| Products | Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. As a… |
| Initiation date | Jan 20, 2014 |
| Report date | Feb 12, 2014 |
| Termination date | Mar 24, 2014 |
| 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: