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.
What this means for you
Illness, injury, or structural failure has been reported. 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 def
- 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.
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