Medtronic EnTrust Escudo ICD Recall for Potential Loss of Therapy
Medtronic is recalling 1,867 EnTrust Escudo ICDs because they may lose high-voltage therapy without a prior alert.
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 3/5 (High).
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 (ICD) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medtronic Inc. is recalling 1,867 units of the EnTrust Escudo D144DRG implantable cardioverter defibrillator (ICD). The device is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for the automated treatment of life-threatening ventricular arrhythmias.
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 the high-voltage circuits, leading to an excessive charge time EOL observation and a loss of therapy.
The affected devices were distributed worldwide and nationwide in the US. Patients with these specific serial numbers should contact their healthcare provider to discuss the recall and potential device replacement.
The recalled product
- Product
- Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
- Affected units
- 1,867
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
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