Medtronic Percepta CRT-P MRI SureScan Devices Recalled for Potential Reset
Medtronic is recalling Percepta CRT-P MRI SureScan devices due to a timing interaction that may cause a device reset.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a risk-of-harm product (implantable cardiac device) where a device reset could impact therapy, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Medtronic Inc. is recalling 6,712 units of the Percepta Quad CRT-P MRI SureScan (REF W4TR01) implantable pulse generators. These devices are used for cardiac resynchronization therapy (CRT-P) to monitor and regulate heart rate in patients with heart failure, atrial arrhythmias, or AV block.
The recall is issued because of a potential for a device reset to occur. This issue is 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 US. Patients with these specific devices should contact their healthcare provider or Medtronic for instructions on how to proceed.
The recalled product
- Product
- Percepta Quad CRT-P MRI SureScan, REF W4TR01 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…
- Hazard
- Affected units
- 6,712
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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