Official recall notice
FDA DeviceClass IINotable
FDA Recall: BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA010
- Recall date
- 2026-08-19
- Brand
- MICROVENTION INC.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Due to an increase rate of balloon pinhole defects.
Recommended action
What to do
5500 devices
Product description
Due to an increase rate of balloon pinhole defects.