St. Jude Medical, Cardiac Rhythm Management Division recalls

St. Jude Medical, Cardiac Rhythm Management Division has 10 recalls on record with the FDA and USDA, the earliest in 2016 and the latest reported on 10 Aug 2022. 7 are still ongoing. The most frequent reason is device malfunction.

Total recalls10since 2016
Last 12 months0reported
Class I110% of total
Ongoing7latest 10 Aug 2022

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 1 10%Class II 9 90%Class III 0 0%

Why st. jude medical, cardiac rhythm management division is recalled

By year

Ongoing st. jude medical, cardiac rhythm management division recalls

7 active

All st. jude medical, cardiac rhythm management division recalls, newest first

10 total
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIMerlin.net recalled by St. Jude Medical, CardiacSt. Jude Medical, Cardiac Rhythm Management DivisionDevice Malfunction44 states
DeviceCLASS IIMerlin PCS 3650 programmer recalled by St. Jude Medical, CardiacSt. Jude Medical, Cardiac Rhythm Management DivisionDevice Malfunction44 states
DeviceCLASS IIMerlin MER37000 programmer recalled by St. Jude Medical, CardiacSt. Jude Medical, Cardiac Rhythm Management DivisionDevice Malfunction44 states
DeviceCLASS IIGallant VR Implantable Cardioverter Defibrillator recalledSt. Jude Medical, Cardiac Rhythm Management DivisionDevice MalfunctionNationwide
DeviceCLASS IIMerlin MER3700 programmer recalled by St. Jude Medical, CardiacSt. Jude Medical, Cardiac Rhythm Management DivisionDevice MalfunctionNationwide
DeviceCLASS IIGallant DR Implantable Cardioverter Defibrillator recalledSt. Jude Medical, Cardiac Rhythm Management DivisionDevice MalfunctionNationwide
DeviceCLASS IIGallant HF Implantable Cardioverter Defibrillator recalledSt. Jude Medical, Cardiac Rhythm Management DivisionDevice MalfunctionNationwide
DeviceCLASS IIEllipse, Tiered-therapy Cardioverter/Defibrillator recalledSt Jude Medical, Cardiac Rhythm Management DivisionDevice Malfunction19 states
DeviceCLASS IIMerlin PCS Programmer recalled by St Jude Medical, CardiacSt Jude Medical, Cardiac Rhythm Management DivisionDevice MalfunctionNationwide
DeviceCLASS IOptisure Dual Coil Defibrillation Leads recalledSt Jude Medical Cardiac Rhythm Management DivisionOtherNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.