Z-2418-2018Class II

Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies...

Name: Z-2418-2018 Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies...
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2018-06-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-06-21 / Terminated / root cause: design

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Product Usage... on 2018-06-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2418-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-21
Posted: 2018-07-10
Terminated: 2021-06-16
Recalling firm: Medtronic, Inc.
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 defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 21-Jun-2018, Medtronic began notifying US follow-up physicians, and Risk Managers of health care facilities of this issue via hand delivery by Field Representatives. In consultation with an Independent Physician Quality Panel, MDT recommends the physicians following patients with affected devices: " Consider scheduling an in-office patient follow-up as soon as possible to assess the potential for this issue per the steps described below. " Use a programmer to ensure the Excessive Charge Time EOL&and the Low Battery Voltage ERI& Patient Alerts have been programmed to On-High " Instruct patients to contact your office if they hear device alert tones. " If this issue has occurred, an EOL: replace device immediately Observation will be displayed on the programmer QuickLook report. Schedule device replacement immediately. The notification provided Patient Management recommendations to ensure patient safety and effective high voltage therapy remain as the device battery voltage approaches its 2.61V ERI threshold.
Quantity in commerce: 3 units
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: Product UPN/GTIN: 00885074300245 Serial Numbers: PNT402938H PNT413911H PNT413995H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2418-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2416-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2417-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2418-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2419-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2420-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10
Z-2421-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-10

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)