Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy
Medtronic is recalling 8,890 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 life-sustaining medical device where failure results in the loss of therapy for life-threatening arrhythmias, meeting the criteria for a Severe rating.
Plain-English summary
Medtronic Inc. is recalling 8,890 units of the EnTrust Dual Chamber Implantable Cardioverter Defibrillator (model D154ATG) with RapidRead Telemetry. The recall is due to a potential for loss of high voltage and anti-tachycardia pacing therapy as the device nears its elective replacement indicator (ERI) voltage.
Under certain circumstances, the device may display an immediate End of Life (EOL) Observation without a prior ERI alert. This can result in insufficient battery capacity to charge high voltage circuits, leading to an excessive charge time EOL Observation and a loss of therapy. The affected devices were distributed worldwide, including nationwide in the US.
Patients with these devices should contact their healthcare provider for evaluation and appropriate management. The recall number is Z-2417-2018.
The recalled product
- Product
- Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing…
- Affected units
- 8,890
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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