St Jude Medical, Crmd
Country not established
- Devices
- 1
- FDA recalls
- 44
At a glance
Market reach
- United States
- FDA recalls
What St Jude Medical, Crmd makes
The company manufactures cardiac monitoring and pacing accessories, including patient cables (e.g., MERLIN PSA Patient Cable EX 3150) and cable adapters (e.g., Cable Adapter EX3170, M Adapter EX3180) designed for use with implantable cardiac devices.
These products are classified as Class II devices under FDA regulations and are authorised via the 510(k) clearance process. The company is based in the United States.
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 44 recalls initiated by St Jude Medical, Crmd, the earliest on 2006-06-01 and the most recent on 2012-04-03. By recorded status: 44 terminated. The reasons filed fall into these groups: software or firmware, sterility or contamination, packaging, electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 3 Apr 2012 Z-1482-2012 Not yet classified Terminated Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these QuickSite and QuickFlex leads.
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- 3 Apr 2012 Z-1483-2012 Not yet classified Terminated Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these QuickSite and QuickFlex leads.
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- 3 Apr 2012 Z-1482-2012 Not yet classified Terminated Visual observations of externalized conductors due to abrasion of the silicone insulation in the distal portion of these QuickSite and QuickFlex leads.
2011
- 28 Nov 2011 Z-0457-2012 Unclassified (pre-2012) Terminated 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.
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- 28 Nov 2011 Z-0458-2012 Unclassified (pre-2012) Terminated 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.
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- 23 Sep 2011 Z-0429-2012 Unclassified (pre-2012) Terminated 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.
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- 23 Sep 2011 Z-0430-2012 Unclassified (pre-2012) Terminated 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.
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- 31 Mar 2011 Z-2733-2011 Unclassified (pre-2012) Terminated 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
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- 28 Nov 2011 Z-0457-2012 Unclassified (pre-2012) Terminated 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.
2008
- 16 Jan 2008 Z-1320-2008 Unclassified (pre-2012) Terminated 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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- 16 Jan 2008 Z-1321-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1322-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1320-2008 Unclassified (pre-2012) Terminated 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.
Show the 25 most recent of 44 recalls
2008
- 16 Jan 2008 Z-1323-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1324-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1325-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1326-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1327-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1328-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1329-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1330-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1331-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1332-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1333-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1334-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1335-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1336-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1337-2008 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 16 Jan 2008 Z-1323-2008 Unclassified (pre-2012) Terminated 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.
Frequently asked questions
How many devices does St Jude Medical, Crmd have in the registry?
The registry currently lists 1 device for St Jude Medical, Crmd. Devices recorded under merged duplicate company entries are counted once.
Which registries list St Jude Medical, Crmd's devices?
Among its 1 most recently registered device, St Jude Medical, Crmd has devices listed in FDA 510(k) (1 device).
What risk classes do St Jude Medical, Crmd's devices fall under?
Among its 1 most recently registered device, the classes recorded for St Jude Medical, Crmd's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for St Jude Medical, Crmd?
FDA recall records list 44 recalls initiated by St Jude Medical, Crmd, the most recent initiated on 3 Apr 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from St Jude Medical, Crmd in the registry?
The most recently registered devices listed for St Jude Medical, Crmd include MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180.