Medtronic Percepta CRT-P MRI SureScan Devices Recalled for Potential Reset
Medtronic is recalling Percepta CRT-P MRI SureScan devices due to a potential device reset caused by a timing interaction between specific diagnostic and pacing features.
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 is classified as FDA Class II, and the hazard involves a potential device reset in a life-sustaining implantable cardiac device, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc. is recalling 3,560 units of Percepta Quad CRT-P MRI SureScan implantable pulse generators (REF W4TR04). These devices are used for cardiac resynchronization therapy (CRT-P) to monitor and regulate heart rate in patients with heart failure who may have atrial arrhythmias or AV block.
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 US.
Patients with these implanted devices should contact their healthcare provider or Medtronic for further instructions regarding the recall and potential device replacement or reprogramming.
The recalled product
- 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…
- Affected units
- 3,560
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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