Recall Z-2412-2018— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2018-06-21, terminated 2020-08-19. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP)..
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-21
- Terminated
- 2020-08-19
- Firm location
- Mounds View, MN, United States
Product description
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.
Reason for recall
Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP).
Data sourced from openFDA. This site is unofficial and independent of the FDA.