Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy
Medtronic is recalling 8,821 EnTrust ICDs due to a potential loss of high voltage therapy near end-of-life. Patients should contact their healthcare provider.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device that provides life-saving therapy for life-threatening arrhythmias. The potential loss of high voltage therapy represents a significant risk of serious injury or death, meeting the criteria for a Severe rating.
Plain-English summary
Medtronic Inc. is recalling 8,821 units of the EnTrust SingleChamber Implantable Cardioverter Defibrillator (ICD) with Atrial and Ventricular Therapies and RapidRead Telemetry, model D154VRC. The recall is due to a potential for loss of high voltage and anti-tachycardia pacing therapy as the devices near their elective replacement indicator (ERI) voltage.
Under certain circumstances, the device may display an immediate End of Life (EOL) Observation without a prior ERI alert. In these cases, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation and a loss of high voltage and anti-tachycardia pacing therapy.
The affected devices were distributed worldwide and nationwide in the US. Patients with these devices should contact their healthcare provider to discuss the recall and determine the appropriate course of action.
The recalled product
- Product
- Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular…
- Affected units
- 8,821
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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 6 products in this recall →Related recalls
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
See all →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
Same hazard · loss of therapy
See all →- HighDeep brain stimulation implant manuals recalled after wire breaks in generators
FDA (Devices) · 2025-09-24
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12
- HighAbbott Infinity 7 Implantable Pulse Generators Recalled for Potentially Shortened Service Life
FDA (Devices) · 2024-07-31
- HighAbbott Infinity 5 Pulse Generator May Fail Prematurely
FDA (Devices) · 2024-07-31
- HighAbbott Infinity 7 Pulse Generator May Have Shorter-Than-Labeled Service Date
FDA (Devices) · 2024-07-31
Similar recalls
- SevereImplantable Cardioverter Defibrillators May Fail During High-Voltage Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereImplantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators Recalled for Reduced Energy Output
FDA (Devices) · 2023-06-28
- CriticalImplantable Cardioverter Defibrillators Recalled for Potential High-Voltage Therapy Failure
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators Recalled for Rare Therapy Delivery Failure
FDA (Devices) · 2023-06-28