Medtronic Percepta CRT-P MRI SureScan Recall for Device Reset Risk
Medtronic is recalling 1,604 Percepta CRT-P MRI SureScan implantable pulse generators due to a potential device reset caused by a timing interaction between diagnostic and pacing features.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (implantable cardiac device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Inc. is recalling 1,604 units of the Percepta CRT-P MRI SureScan implantable pulse generator. These devices are used to monitor and regulate heart rate in patients with heart failure, providing bradycardia pacing and cardiac resynchronization therapy. The recall is due to a potential device reset caused by a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing (VSP) feature.
The affected devices were distributed worldwide and nationwide in the United States. The source text does not specify the number of patients affected or report any illnesses or injuries associated with this defect.
Patients with these devices should contact their healthcare provider or Medtronic for instructions on how to proceed. The recall is classified as Class II by the FDA, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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
- Affected units
- 1,604
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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