Device recall
Z-0287-2011: enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as…
FDA device recall · Class II · Greatbatch Medical
Key facts
| Recall number (Z-number) | Z-0287-2011 |
|---|---|
| Recall event | 56324 |
| Product | enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm. Distributed by Guidant/CPI. Contents in unopened, undamaged package have been sterilized by ethylene oxide gas. Manufactured by enpath medical, Inc., 2300 Berkshire Lane North… |
| Product code | DTB |
| Recalling firm | Greatbatch Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2012 |
| FEI number | 2183787 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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