Medtronic EnTrust Escudo ICD Recall for Potential Loss of Therapy
Medtronic is recalling EnTrust Escudo ICDs due to a potential loss of high voltage and anti-tachycardia pacing therapy as the battery nears its end of life.
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 medical device intended to treat life-threatening arrhythmias. The potential loss of therapy in a critical life-support device represents a significant risk of serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Medtronic Inc. is recalling 5,057 units of the EnTrust Escudo D144VRC implantable cardioverter defibrillator (ICD). These devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for the automated treatment of life-threatening ventricular arrhythmias. The affected units were distributed worldwide and 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 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 subsequent loss of therapy.
Patients with these specific devices should contact their healthcare provider to discuss the recall and determine if any action is necessary. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Medtronic EnTrust Escudo D144VRC (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
- 5,057
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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