St. Jude Medical, Atrial Fibrillation Division, Inc.
St. Jude Medical, Atrial Fibrillation Division, Inc. appears in FDA public data with 1 recall, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0814-2024, Class II) was initiated on December 18, 2023.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 0
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0814-2024 | Class II | TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal | December 18, 2023 |