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St. Jude Medical, Inc. Recalls

32 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for St. Jude Medical, Inc..

32Total Recalls
4Critical
2.2MUnits Affected
Jun 20, 2019Most Recent
All Recalls

Every St. Jude Medical, Inc. Recall

Sorted by most recent. Click any recall for full details.

32 recalls
CriticalFDA
St Jude Medical Inc.
ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
Medical Implants·47 affected·Jun 20, 2019
CriticalFDA
St Jude Medical Inc.
ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
Medical Implants·21 affected·Jun 20, 2019
CriticalFDA
St Jude Medical Inc.
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585
Cardiac Devices·15 affected·Jun 20, 2019
High RiskFDA
St. Jude Medical, Inc.
St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Pl...
Medical Implants·0 affected·Oct 11, 2018
High RiskFDA
St Jude Medical Inc.
Merlin PCS programmer (Model # 3650), Software (Model # 3330)
Medical Devices·71,651 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-4...
Medical Devices·40,738 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-...
Medical Devices·81,338 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, ...
Medical Devices·131,093 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 10...
Medical Devices·22,132 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/1000431...
Medical Devices·68,117 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001,...
Medical Devices·37,485 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 10011620...
Medical Devices·139,351 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-3...
Medical Devices·71,651 affected·Apr 16, 2018
High RiskFDA
St Jude Medical Inc.
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring...
Cardiac Devices·986 affected·Apr 16, 2018
High RiskFDA
St. Jude Medical, Inc.
Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
Medical Implants·3,119 affected·Sep 12, 2017
High RiskFDA
St Jude Medical Inc.
Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is i...
Medical Implants·164,366 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to b...
Medical Implants·101 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI...
Medical Implants·529,912 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transm...
Medical Implants·495,011 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse ge...
Medical Implants·2,741 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a porta...
Medical Implants·10,453 affected·Aug 28, 2017
High RiskFDA
St Jude Medical Inc.
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a sin...
Medical Implants·102,684 affected·Aug 28, 2017
High RiskFDA
St. Jude Medical, Inc.
Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device design...
Medical Implants·40 affected·Jun 2, 2017
High RiskFDA
St. Jude Medical, Inc.
Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device desi...
Medical Implants·443 affected·Jun 2, 2017
High RiskFDA
St. Jude Medical, Inc.
Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device design...
Medical Implants·373 affected·Jun 2, 2017
High RiskFDA
St. Jude Medical, Inc.
Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator ...
Medical Implants·9,529 affected·Jun 2, 2017
High RiskFDA
St. Jude Medical, Inc.
Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device design...
Medical Implants·54 affected·Jun 2, 2017
High RiskFDA
St. Jude Medical, Inc.
Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator ...
Medical Implants·8,780 affected·Jun 2, 2017
CriticalFDA
St Jude Medical Inc.
Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, C...
Medical Implants·204,785 affected·Oct 10, 2016
High RiskFDA
St Jude Medical Inc.
Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD ...
Medical Implants·127 affected·Mar 31, 2016
High RiskFDA
St. Jude Medical, Inc.
Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicate...
Medical Devices·4 affected·Jul 29, 2014
RecallFDA
St Jude Medical Inc
Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Mi...
Cardiac Devices·26 affected·Mar 28, 2012