Device recall
Z-3011-2020: Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage…
FDA device recall · Class II · Irvine Biomedical Inc, a St. Jude Medical Co.
Key facts
| Recall number (Z-number) | Z-3011-2020 |
|---|---|
| Recall event | 86328 |
| Product | Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at… |
| Product code | DRF |
| Recalling firm | Irvine Biomedical Inc, a St. Jude Medical Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 31, 2023 |
| 510(k) numbers | K961924 |
| FEI number | 1000519796 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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