St. Jude Medical, Cardiac Rhythm Management Division
St. Jude Medical, Cardiac Rhythm Management Division appears in FDA public data with 8 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1496-2022, Class II) was initiated on June 17, 2022.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Known Names
st jude medical cardiac rhythm management division, st. jude medical, cardiac rhythm management division, st jude medical, cardiac rhythm management division
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1496-2022 | Class II | Merlin 2 PCS MER37000 programmer Model MER3400 software | June 17, 2022 |
| Z-1495-2022 | Class II | Merlin PCS 3650 programmer Model 3330 software | June 17, 2022 |
| Z-1497-2022 | Class II | Merlin.net model MN5000 Software | June 17, 2022 |
| Z-0990-2022 | Class II | Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q | March 10, 2022 |
| Z-0988-2022 | Class II | Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q | March 10, 2022 |
| Z-0965-2022 | Class II | Merlin 2 PCS MER3700 programmer Model MER3400 software | March 10, 2022 |
| Z-0964-2022 | Class II | Merlin PCS 3650 programmer Model 3330 software | March 10, 2022 |
| Z-0989-2022 | Class II | Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q | March 10, 2022 |