Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Percepta family: Percepta CRT-P MRI SureScan, Percepta Quad CRT-P MRI SureScan. 2. Serena family: Serena CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan. 3. Solara family: Solara CRT-P MRI SureScan, Solara Quad CRT-P MRI SureScan. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Percepta family: Percepta CRT-P MRI SureScan, Percepta Quad CRT-P MRI SureScan. 2. Serena family: Serena CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan. 3. Solara family: Solara CRT-P MRI SureScan, Solara Quad CRT-P MRI SureScan.
Brand
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrh due to A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
Recommended Action
Per FDA guidance
Beginning 06-APR-2021, Medtronic notified risk managers and practice managers of the field corrective action notification via 2- day UPS delivery of the consignee letter. Consignees were asked to confirm receipt of the notification. Medtronic Field Representatives have been instructed to begin installation of the software update. Outside the United States (OUS), communication began on 06- APR-2021 using locally approved methods. Confirmation will be obtained per locally approved methods. Medtronic Field Representatives will begin installation of the software update as it is available locally. A courtesy notification will be provided to physicians with affected devices.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026