Device recall
Z-0991-2011: EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile…
FDA device recall · Class II · Edwards Lifesciences Llc
Key facts
| Recall number (Z-number) | Z-0991-2011 |
|---|---|
| Recall event | 57522 |
| Product | EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA 92614. The EndoPlege coronary sinus catheter is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to… |
| Product code | DWF |
| Recalling firm | Edwards Lifesciences Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 27, 2011 |
| 510(k) numbers | K964248 |
| FEI number | 1713910 |
At a glance
- 1–9 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