Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Medtronic EnTrust Escudo D144DRG - Class 2 Recall
Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2018 Category: Medical Devices Source Type: alerts
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies an - Class 2 Recall
Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2018 Category: Medical Devices Source Type: alerts
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Percepta CRTP MRI SureScan - Class 2 Recall
Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2018 Category: Medical Devices Source Type: alerts
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Percepta CRTP MRI SureScan - Class 2 Recall
Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2018 Category: Medical Devices Source Type: alerts
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Percepta Quad CRTP MRI SureScan - Class 2 Recall
Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2018 Category: Medical Devices Source Type: alerts
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Percepta Quad CRTP MRI SureScan - Class 2 Recall
Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 11, 2018 Category: Medical Devices Source Type: alerts
St Jude Medical Inc. - Merlin PCS Programmer Software - Class 2 Recall
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 30, 2018 Category: Medical Devices Source Type: alerts
Draegar Medical Systems, Inc. - Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms) - Class 2 Recall
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The ...
Source: Medical Device Recalls - May 15, 2018 Category: Medical Devices Source Type: alerts
Spacelabs Healthcare Inc - Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1 - Class 2 Recall
Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 26, 2018 Category: Medical Devices Source Type: alerts
Fukuda Denshi Co., Ltd. - Class 2 Recall
Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac outpu...
Source: Medical Device Recalls - December 7, 2017 Category: Medical Devices Source Type: alerts
St Jude Medical Inc. - Unify and Unify Assura - Class 1 Recall
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or...
Source: Medical Device Recalls - October 11, 2017 Category: Medical Devices Source Type: alerts
St Jude Medical Inc. - Fortify, Fortify Assura - Class 1 Recall
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (...
Source: Medical Device Recalls - October 11, 2017 Category: Medical Devices Source Type: alerts
Sorin Group Italia SRL - CRF - Platinium DR DF4 1540 - Class 2 Recall
Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 29, 2017 Category: Medical Devices Source Type: alerts
Sorin Group Italia SRL - CRF - Platinium CRTD 1741 - Class 2 Recall
Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 29, 2017 Category: Medical Devices Source Type: alerts
Sorin Group Italia SRL - CRF - Platinium CRT DF1 1711 - Class 2 Recall
Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 29, 2017 Category: Medical Devices Source Type: alerts
