Recall Z-0962-2017— Medtronic Inc., Cardiac Rhythm and Heart Failure
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure, initiated 2016-12-09, terminated 2019-07-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.. Reason: During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI and Claria MRI CRT -D devices may appear to be enabled when it is not active..
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-09
- Terminated
- 2019-07-16
- Firm location
- Mounds View, MN, United States
Product description
Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.
Reason for recall
During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI and Claria MRI CRT -D devices may appear to be enabled when it is not active.
Data sourced from openFDA. This site is unofficial and independent of the FDA.