Medtronic Inc., Cardiac Rhythm and Heart Failure ( Recall: Percepta Quad CRT-P MRI SureSca
Medtronic Inc., Cardiac Rhythm and Heart Failure ( Recall: Percepta Quad CRT-P MRI SureSca is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF); Product: Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
|---|---|
| Product | 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. |
| 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). |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US Nationwide |
| Recall initiated | 20180621 |
| Recall number | Z-2415-2018 |
| Category | device |
| State | MN |
| Country | United States |
$29/mo
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