Device recall
Z-1483-2012: Cardiac Resynchronization Therapy (CRT) Leads Trade Name: QuickFlex, QuickFlex…
FDA device recall · Class II · St Jude Medical CRMD
Key facts
| Recall number (Z-number) | Z-1483-2012 |
|---|---|
| Recall event | 61656 |
| Product | Cardiac Resynchronization Therapy (CRT) Leads Trade Name: QuickFlex, QuickFlex XL Model Numbers: QuickFlex and QuickFlex XL: model 1156T, model 1158T Intended use: Left Ventricular Cardiac Resynchronization Therapy Lead. |
| Product code | NIK |
| Recalling firm | St Jude Medical CRMD |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 17, 2012 |
| PMA numbers | P030054, P030054S049 |
| FEI number | 2017865 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database