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.
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 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 bradyc
- 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
See all →- CriticalMedtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
Same hazard · device reset
See all →- ModeratePhilips Telemetry Monitor 5500 Device Reset Risk Recall
FDA (Devices) · 2026-07-01
- HighSpinal Cord Stimulation Devices May Reset During Charging, Causing Transient Therapy Loss
FDA (Devices) · 2024-08-21
- HighVercise Genus Deep Brain Stimulation Device May Reset During Charging
FDA (Devices) · 2024-06-05
- SevereVITALIO DR EL Pacemakers Recalled Due to Battery-Related Device Resets
FDA (Devices) · 2021-07-21
- HighMedtronic Percepta CRT-P MRI SureScan Recall for Device Reset Risk
FDA (Devices) · 2018-07-18