Device recall
Z-0052-2008: Guidant CONTAK RENEWAL 3 (Models H170, H173, H175), Guidant CONTAK RENEWAL 3 HE…
FDA device recall · Class II · Boston Scientific CRM Corp
Key facts
| Recall number (Z-number) | Z-0052-2008 |
|---|---|
| Recall event | 44793 |
| Product | Guidant CONTAK RENEWAL 3 (Models H170, H173, H175), Guidant CONTAK RENEWAL 3 HE (Models H177, H179). Guidant CONTAK RENEWAL 4 (Models H190,H195) *, Guidant CONTAK RENEWAL 4 HE (Models H197, H199)* Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline… |
| Product code | LWP |
| Recalling firm | Boston Scientific CRM Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 23, 2007 |
| PMA numbers | P010012, P010012-RENE |
| 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