St Jude Medical Inc. recalls

47 recalls on record · latest: June 20, 2019

Official U.S. recall history for St Jude Medical Inc., compiled from official government records.

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St Jude Medical Inc. recalls ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)

June 20, 2019 · Medical device recalls High risk Electrical failures were identified in cardioverter defibrillators (ICDs) due t…

St Jude Medical Inc. recalls ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)

June 20, 2019 · Medical device recalls High risk Electrical failures were identified in cardioverter defibrillators (ICDs) due t…

St Jude Medical Inc. recalls ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585

June 20, 2019 · Medical device recalls High risk Electrical failures were identified in cardioverter defibrillators (ICDs) due t…

St Jude Medical Inc. recalls ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738

June 20, 2019 · Medical device recalls High risk Electrical failures were identified in cardioverter defibrillators (ICDs) due t…

St Jude Medical Inc. recalls ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615

June 20, 2019 · Medical device recalls High risk Electrical failures were identified in cardioverter defibrillators (ICDs) due t…

St Jude Medical Inc. recalls ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)

June 20, 2019 · Medical device recalls High risk Electrical failures were identified in cardioverter defibrillators (ICDs) due t…

St. Jude Medical, Inc. recalls St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St.…

October 11, 2018 · Medical device recalls Moderate risk The most proximal unsegmented electrode of the Deep Brain Stimulation leads, ma…

St Jude Medical Inc. recalls Merlin PCS programmer (Model # 3650), Software (Model # 3330)

April 16, 2018 · Medical device recalls Moderate risk The firm is releasing new firmware for high voltage implantable cardiac devices…

St Jude Medical Inc. recalls Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 1000419…

April 16, 2018 · Medical device recalls Moderate risk The firm is releasing new firmware for high voltage implantable cardiac devices…

St Jude Medical Inc. recalls Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041…

April 16, 2018 · Medical device recalls Moderate risk The firm is releasing new firmware for high voltage implantable cardiac devices…

St Jude Medical Inc. recalls Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40…

April 16, 2018 · Medical device recalls Moderate risk The firm is releasing new firmware for high voltage implantable cardiac devices…

St Jude Medical Inc. recalls Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/1…

April 16, 2018 · Medical device recalls Moderate risk The firm is releasing new firmware for high voltage implantable cardiac devices…

St Jude Medical Inc. recalls Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-4…

April 16, 2018 · Medical device recalls Moderate risk The firm is releasing new firmware for high voltage implantable cardiac devices…

St Jude Medical Inc. recalls Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/5…

April 16, 2018 · Medical device recalls Moderate risk The firm is releasing new firmware for high voltage implantable cardiac devices…

St Jude Medical Inc. recalls Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060…

April 16, 2018 · Medical device recalls Moderate risk The firm is releasing new firmware for high voltage implantable cardiac devices…

St Jude Medical Inc. recalls Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-…

April 16, 2018 · Medical device recalls Moderate risk The firm is releasing new firmware for high voltage implantable cardiac devices…

St Jude Medical Inc. recalls Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115,…

April 16, 2018 · Medical device recalls Moderate risk The firm is releasing new firmware for high voltage implantable cardiac devices…

St Jude Medical Inc. recalls Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/1…

April 16, 2018 · Medical device recalls Moderate risk The firm is releasing new firmware for high voltage implantable cardiac devices…

St Jude Medical Inc. recalls Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/…

April 16, 2018 · Medical device recalls Moderate risk The firm is releasing new firmware for high voltage implantable cardiac devices…

St Jude Medical Inc. recalls St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for…

April 16, 2018 · Medical device recalls Moderate risk The firm is advising physicians that exposure to sub-freezing temperatures duri…

St Jude Medical Inc. recalls Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to supp…

April 16, 2018 · Medical device recalls Moderate risk The firm is advising physicians that exposure to sub-freezing temperatures duri…

St. Jude Medical, Inc. recalls Proclaim DRG Implantable Pulse Generator, Model Number 3664

March 9, 2018 · Medical device recalls Moderate risk The firm received complaints of error messages that occurred during routine imp…

St. Jude Medical, Inc. recalls Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663

September 12, 2017 · Medical device recalls Moderate risk Analysis of the difference between the actual device longevity and the battery…

St. Jude Medical, Inc. recalls Proclaim DRG Implantable Pulse Generator Model 3664

September 12, 2017 · Medical device recalls Moderate risk Analysis of the difference between the actual device longevity and the battery…

St. Jude Medical, Inc. recalls Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662,…

September 12, 2017 · Medical device recalls Moderate risk Analysis of the difference between the actual device longevity and the battery…

St Jude Medical Inc. recalls Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify A…

August 28, 2017 · Medical device recalls High risk The device may exhibit premature battery depletion.

St Jude Medical Inc. recalls Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Mo…

August 28, 2017 · Medical device recalls High risk The device may exhibit premature battery depletion.

St Jude Medical Inc. recalls Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generat…

August 28, 2017 · Medical device recalls Moderate risk New pacemaker firmware was developed to further mitigate the risk of unauthoriz…

St Jude Medical Inc. recalls PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generato…

August 28, 2017 · Medical device recalls Moderate risk New pacemaker firmware was developed to further mitigate the risk of unauthoriz…

St Jude Medical Inc. recalls Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222,…

August 28, 2017 · Medical device recalls Moderate risk New pacemaker firmware was developed to further mitigate the risk of unauthoriz…

St Jude Medical Inc. recalls Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The M…

August 28, 2017 · Medical device recalls Moderate risk New pacemaker firmware was developed to further mitigate the risk of unauthoriz…

St Jude Medical Inc. recalls PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable p…

August 28, 2017 · Medical device recalls Moderate risk New pacemaker firmware was developed to further mitigate the risk of unauthoriz…

St Jude Medical Inc. recalls Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Prog…

August 28, 2017 · Medical device recalls Moderate risk New pacemaker firmware was developed to further mitigate the risk of unauthoriz…

St Jude Medical Inc. recalls Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Impl…

August 28, 2017 · Medical device recalls Moderate risk New pacemaker firmware was developed to further mitigate the risk of unauthoriz…

St Jude Medical Inc. recalls PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse g…

August 28, 2017 · Medical device recalls Moderate risk New pacemaker firmware was developed to further mitigate the risk of unauthoriz…

St Jude Medical Inc. recalls PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanentl…

August 28, 2017 · Medical device recalls Moderate risk New pacemaker firmware was developed to further mitigate the risk of unauthoriz…

St Jude Medical Inc. recalls PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse genera…

August 28, 2017 · Medical device recalls Moderate risk New pacemaker firmware was developed to further mitigate the risk of unauthoriz…

St. Jude Medical, Inc. recalls Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic…

June 2, 2017 · Medical device recalls Moderate risk The firm discovered a risk of loss of Neuromodulation therapy due to exposure o…

St. Jude Medical, Inc. recalls Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electroni…

June 2, 2017 · Medical device recalls Moderate risk The firm discovered a risk of loss of Neuromodulation therapy due to exposure o…

St. Jude Medical, Inc. recalls Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic…

June 2, 2017 · Medical device recalls Moderate risk The firm discovered a risk of loss of Neuromodulation therapy due to exposure o…

St. Jude Medical, Inc. recalls Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pu…

June 2, 2017 · Medical device recalls Moderate risk The firm discovered a risk of loss of Neuromodulation therapy due to exposure o…

St. Jude Medical, Inc. recalls Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic…

June 2, 2017 · Medical device recalls Moderate risk The firm discovered a risk of loss of Neuromodulation therapy due to exposure o…

St. Jude Medical, Inc. recalls Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pu…

June 2, 2017 · Medical device recalls Moderate risk The firm discovered a risk of loss of Neuromodulation therapy due to exposure o…

St Jude Medical Inc. recalls Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-4…

October 10, 2016 · Medical device recalls High risk St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardia…

St Jude Medical Inc. recalls Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-4…

October 10, 2016 · Medical device recalls High risk St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardia…

St Jude Medical Inc. recalls Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model N…

October 10, 2016 · Medical device recalls High risk St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardia…

St Jude Medical Inc. recalls Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage…

March 31, 2016 · Medical device recalls Moderate risk St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibri…