Device recall
Z-2912-2026: BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL…
FDA device recall · Class II · MICROVENTION INC.
Key facts
| Recall number (Z-number) | Z-2912-2026 |
|---|---|
| Recall event | 98909 |
| Product | BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. |
| Product code | DQY |
| Recalling firm | MICROVENTION INC. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K193607 |
| FEI number | 3013556777 |
At a glance
- 1–9 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