Device recall
Z-1038-05: INTELIS II (model nos. 1349, 1384, 1385, 1483, 1484, 1485 and 1499) pacemaker…
FDA device recall · Class I · Guidant Corporation
Key facts
| Recall number (Z-number) | Z-1038-05 |
|---|---|
| Recall event | 32681 |
| Product | INTELIS II (model nos. 1349, 1384, 1385, 1483, 1484, 1485 and 1499) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . INTELIS II pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering both adaptive-rate… |
| Product code | LWP |
| Recalling firm | Guidant Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 5, 2007 |
| PMA numbers | P940031 |
| FEI number | 2124215 |
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