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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan IC
Recalled February 28, 2018 · FDA recall Z-0588-2018 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D). · FDA Class I
Units
951 devices total
Sold at
US Nationwide Distribution.
Description
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Product
Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); b. Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4); EXPANSION: c. Visia AF MRI S VR SureScan ICD DF1 (Product No. DVFC3D1); d. Visia AF MRI VR SureScan DF4 (Product No. DVFC3D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →