Home / Companies / St. Jude Medical, Cardiac Rhythm Management Division

St. Jude Medical, Cardiac Rhythm Management Division

FDA Regulatory Profile

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

NumberClassProductDate
Z-1496-2022Class IIMerlin 2 PCS MER37000 programmer Model MER3400 softwareJune 17, 2022
Z-1495-2022Class IIMerlin PCS 3650 programmer Model 3330 softwareJune 17, 2022
Z-1497-2022Class IIMerlin.net model MN5000 SoftwareJune 17, 2022
Z-0964-2022Class IIMerlin PCS 3650 programmer Model 3330 softwareMarch 10, 2022
Z-0988-2022Class IIGallant DR Implantable Cardioverter Defibrillator REF # CDDRA500QMarch 10, 2022
Z-0965-2022Class IIMerlin 2 PCS MER3700 programmer Model MER3400 softwareMarch 10, 2022
Z-0989-2022Class IIGallant VR Implantable Cardioverter Defibrillator REF # CDVRA500QMarch 10, 2022
Z-0990-2022Class IIGallant HF Implantable Cardioverter Defibrillator REF# CDHFA500QMarch 10, 2022