Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2018 - (Recall #: Z-2418-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 defibrillation for automated treatment of life-threatening ventricular arrhythmias.

Product Classification:

Class II

Date Initiated: June 21, 2018

Date Posted: July 18, 2018

Recall Number: Z-2418-2018

Event ID: 80379

Reason for Recall:

Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation, leading to a loss of high voltage and anti-tachycardia pacing therapy.

Status: Terminated

Product Quantity: 3 units

Code Information:

Product UPN/GTIN: 00885074300245 Serial Numbers: PNT402938H PNT413911H PNT413995H

Distribution Pattern:

Worldwide Distribution - US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated