Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy
Medtronic is recalling 3 EnTrust ICDs because they may lose high voltage therapy near battery end-of-life without prior warning.
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 structural defect in a life-saving medical device that can lead to loss of therapy for life-threatening arrhythmias, meeting the criteria for Severe severity.
Plain-English summary
Medtronic Inc. is recalling 3 units of the EnTrust SingleChamber Implantable Cardioverter Defibrillator (model D153VRC) with RapidRead Telemetry. The recall involves specific serial numbers: PNT402938H, PNT413911H, and PNT413995H. The devices were distributed worldwide, including nationwide in the US.
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 triggering a prior ERI alert. This can result in insufficient battery capacity to charge the high voltage circuits, leading to an excessive charge time EOL Observation and a loss of therapy.
The source text does not specify a date for the recall or provide specific instructions for consumers beyond the identification of the affected units. Patients with these specific devices should contact their healthcare provider or Medtronic for guidance on monitoring and potential replacement.
The recalled product
- Product
- Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular…
- Affected units
- 3
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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