ST. Jude Medical, Crmd

FDA adverse event reports naming ST. Jude Medical, Crmd as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ST. JUDE MEDICAL, CRMD.

Total reports: 1,563
Deaths: 0
Injuries: 381
Malfunctions: 1,164

Reports per year

Source: FDA adverse event reports by year received, 1999–2015. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

Recent recalls

2012-05-03TerminatedDevice Design
Cardiac Resynchronization Therapy (CRT) Leads. Trade Name: QuickSite, QuickSite XL Model Numbers: QuickSite and QuickSite XL: Models 1056T, model 1058T Intended use: Left Ventricular Cardiac Resynchronization Therapy Lead
Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these QuickSite and QuickFlex leads.
2012-05-03TerminatedDevice Design
Cardiac Resynchronization Therapy (CRT) Leads Trade Name: QuickFlex, QuickFlex XL Model Numbers: QuickFlex and QuickFlex XL: model 1156T, model 1158T Intended use: Left Ventricular Cardiac Resynchronization Therapy Lead.
Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these QuickSite and QuickFlex leads.
2012-01-11TerminatedPending
Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements.These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false.
2012-01-11TerminatedPending
Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements. These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false.
2012-01-11TerminatedDevice Design
St. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Product Usage: These Silicone transvenous high voltage (HV) leads connect an implantable cardioverter-defibrillator (lCD or CRT-D) to cardiac tissue to monitor and regulate a patients heart rate by providing pacing therapy and/or tachyarrhythmia therapy.
St. Jude Medical has confirmed the failures associated with all cause insulation failure on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads with specific emphasis on externalized conductors.
2012-01-11TerminatedDevice Design
St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 Product Usage: These Silicone transvenous high voltage (HV) leads connect an implantable cardioverter-defibrillator (lCD or CRT-D) to cardiac tissue to monitor and regulate a patients heart rate by providing pacing therapy and/or tachyarrhythmia therapy.
The recall was initiated because St. Jude Medical has confirmed the failures associated with all cause insulation failure on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads with specific emphasis on externalized conductors.
2011-07-05TerminatedSoftware change control
SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia
The recall was initiated because St. Jude Medical made new software available for the SJM Confirm DM2100 implantable cardiac monitor (ICM) that incorporates enhancements to the devices sensing algorithm. These enhancements are intended to provide improved sensitivity and specificity for diagnosing arrhythmias. The user is presented with the option to upgrade new software into the SJM Confirm ICM
2008-08-19TerminatedSoftware design
Implantable Cardioverter Defibrillator EPIC VR Tiered-therapy Cardioverter/Defibrillator, Model V-197
A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an arrhythmia. If an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
2008-08-19TerminatedSoftware design
Implantable Cardioverter Defibrillator EPIC DR Tiered-Therapy Cardioverter/Defibrillator, Model V-235
A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an arrhythmia. If an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
2008-08-19TerminatedSoftware design
Implantable Cardioverter Defibrillator EPIC HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-337
A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an arrhythmia. If an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.

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