Device recall
Z-1035-05: PULSAR MAX II (model nos. 1180, 1181 and 1280) pacemaker. Sterilized with…
FDA device recall · Class I · Guidant Corporation
Key facts
| Recall number (Z-number) | Z-1035-05 |
|---|---|
| Recall event | 32681 |
| Product | PULSAR MAX II (model nos. 1180, 1181 and 1280) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . PULSAR MAX II pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various… |
| 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