Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy
Medtronic is recalling 103 EnTrust Dual Chamber ICDs because they may lose high voltage and anti-tachycardia pacing therapy near end-of-life without prior warning.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (loss of life-saving therapy) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medtronic Inc. is recalling 103 units of the EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry (Model D153ATG). The recall covers devices distributed worldwide and in the US nationwide.
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. 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.
Patients with affected devices should contact their healthcare provider or Medtronic for instructions on monitoring and potential replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing
- Affected units
- 103
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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