Boston Scientific Corporation - VALITUDE X4 CRTP (Cardiac Resynchronization Therapy Pacemaker) - Class 2 Recall
VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 28, 2018 Category: Medical Devices Source Type: alerts

Boston Scientific Corporation - VISIONIST X4 CRTP (Cardiac Resynchronization Therapy Pacemaker) - Class 2 Recall
VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 28, 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

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 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 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) - Claria MRI CRTD, Claria MRI Quad CRTD - Class 1 Recall
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 2, 2018 Category: Medical Devices Source Type: alerts

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Amplia MRI CRTD, Amplia MRI Quad CRTD - Class 1 Recall
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 2, 2018 Category: Medical Devices Source Type: alerts

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Compia MRI CRTD, Compia MRI Quad CRTD, - Class 1 Recall
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 2, 2018 Category: Medical Devices Source Type: alerts

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Amplia MRI CRTD, Amplia MRI Quad CRTD - Class 1 Recall
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 2, 2018 Category: Medical Devices Source Type: alerts

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - Viva Quad S CRTD, Viva Quad XT CRTD, Viva S CRTD, Viva XT CRTD, - Class 1 Recall
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No. DTBA1D1); e. Viva XT CRT-D DF4 (Product No. DTBA1D4) (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 2, 2018 Category: Medical Devices Source Type: alerts

Boston Scientific Corporation - VIGILANT X4 CRTD - Class 2 Recall
VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: (1) Moderate to severe heart failure (NYHA Class III-IV) with EF d 35% and QRS duration e 120 ms; (2) Left bundle branch block (LBBB) with QRS duration e 130 ms, EF d 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 9, 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

Medtronic Inc., Cardiac Rhythm and Heart Failure - Viva ICD - Class 2 Recall
Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DT8A1D1, DT8A1D4 VIVASCRT-D DT881D1, DT881D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT -D) is a multiprogrammable cardiac device that monitors and regulates the patient s heart rate by providing single or dual chamber, rate responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 26, 2016 Category: Medical Equipment Source Type: alerts

Boston Scientific Corporation - Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter - Class 2 Recall
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead Delivery System is designed for venous use to aid in the selective placement of cardiac resynchronization therapy (CRT) implantable venous leads in the cardiac vasculature. The catheter shafts are comprised of a PTFE inner liner, a reinforcing layer of stainless steel braid, and an outer polymer jacket. The distal end has a radiopaque polymer tip, while the proximal end has a hub with flush luer fitting to allow flush, contrast inje...
Source: Medical Device Recalls - January 6, 2016 Category: Medical Equipment Source Type: alerts

Boston Scientific CRM Corp - Boston Scientific COGNIS CRTD - Class 2 Recall
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration> or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia t...
Source: Medical Device Recalls - October 19, 2014 Category: Medical Equipment Source Type: alerts

Boston Scientific CRM Corp - Boston Scientific COGNIS CRTD - Class 2 Recall
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 18, 2013 Category: Medical Equipment Source Type: alerts