Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Percepta CRT-P MRI SureScan Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Due to Potential for a device reset to occur in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) directly.
Affected Products
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.
Quantity: 1604 units
Why Was This Recalled?
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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 198 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report