Device recall
Z-1193-06: VITALITY HE (model T180) Implantable Cardioverter Defibrillator (ICD). Sterile…
FDA device recall · Class II · Guidant Corporation
Key facts
| Recall number (Z-number) | Z-1193-06 |
|---|---|
| Recall event | 35537 |
| Product | VITALITY HE (model T180) Implantable Cardioverter Defibrillator (ICD). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. This ICD is designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and… |
| Product code | LWP |
| Recalling firm | Guidant Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 6, 2007 |
| PMA numbers | P960040, P960040S053 |
| 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