Lower riskMedical device recall · FDA · Published June 21, 2018
Medtronic EnTrust ICDs: Risk of losing heart therapy as batteries near end of life
Medtronic recalls EnTrust dual-chamber ICDs with potential loss of heart therapy as battery capacity drops near replacement. Affected devices may show end-of-life warnings without prior alerts.
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.
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📍Recalling firmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)8200 Coral Sea St Ne · Mounds View, MN 55112-4391
✎ GovInfoNow plain-language explainer
Medtronic is recalling certain EnTrust dual-chamber implantable cardioverter defibrillators that may lose heart therapy as battery capacity decreases near replacement. This could lead to a loss of critical pacing and defibrillation functions if the device fails to alert before battery depletion. Read more at govinfonow.com/recall/70799-medtronic-entrust-icds-risk-of-losing-heart-therapy-as-batteries.
“Medtronic EnTrust ICDs: Risk of losing heart therapy as batteries near end of life.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70799-medtronic-entrust-icds-risk-of-losing-heart-therapy-as-batteries. Based on FDA recall #Z-2416-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2416-2018%22&limit=1).
The FDA announced on June 21, 2018, that Medtronic Inc. is recalling EnTrust and Escudo implantable cardioverter defibrillators due to a potential loss of high voltage therapy as batteries near depletion. The agency classified the recall as Class II.
How to tell if you have it
Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies
UPC 00721902791130
UPC 00721902791147
UPC 00885074299907
UPC 00885074300207
The hazard
According to the FDA, devices near their elective replacement indicator voltage may display an immediate End of Life observation without prior warning. This can result in excessive charge times and a loss of high voltage and anti-tachycardia pacing therapy.
Context
GovInfoNow's records show Medtronic has issued 29 other recalls since December 19, 2017. Other recent recalls include Medtronic CRTD DTMB2D1 Implantable Defibrillators on May 10, 2023, and Cobalt and Crome ICDs on June 22, 2022. Similar product recalls include the Medtronic Sphere-9 Catheter on March 11, 2026, and Thoratec HeartMate 3 LVAS Kits on May 13, 2026.
How to tell if you have this one
Check your device's serial number against the list provided in the recall. The affected models include EnTrust Dual Chamber ICDs with specific serial numbers starting with PNR100502Q through PNR100270Q.
Brand
Medtronic
Product
Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and
Category
Medical device
FDA recall event · 6 products
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide Distribution - US Nationwide
Recall number
Product, codes & lots
Quantity
Z-2416-2018
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 atrial tachyarrhythmias. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.; Product UPN/GTIN: 00721902791130 Serial Numbers: PNR100502Q PNR100510Q PNR100522Q PNR100535Q Product UPN/GTIN: 00721902791147 Serial Numbers: PNR100129Q PNR100130Q PNR100131Q PNR100134Q PNR100135Q PNR100138Q PNR100139Q PNR100141Q PNR100143Q PNR100144Q PNR100146Q PNR100147Q PNR100150Q PNR100151Q PNR100153Q PNR100154Q PNR100155Q PNR100156Q PNR100157Q PNR100160Q PNR100161Q PNR100162Q PNR100163Q PNR100164Q PNR100165Q PNR100166Q PNR100167Q PNR100168Q PNR100169Q PNR100174Q PNR100175Q PNR100176Q PNR100178Q PNR100182Q PNR100183Q PNR100184Q PNR100185Q PNR100188Q PNR100191Q PNR100192Q PNR100193Q PNR100195Q PNR100196Q PNR100197Q PNR100198Q PNR100200Q PNR100204Q PNR100208Q PNR100210Q PNR100211Q PNR100212Q PNR100213Q PNR100215Q PNR100216Q PNR100217Q PNR100218Q PNR100219Q PNR100220Q PNR100221Q PNR100222Q PNR100223Q PNR100224Q PNR100225Q PNR100226Q PNR100227Q PNR100228Q PNR100229Q PNR100230Q PNR100233Q PNR100234Q PNR100236Q PNR100237Q PNR100238Q PNR100239Q PNR100241Q PNR100242Q PNR100243Q PNR100244Q PNR100245Q PNR100247Q PNR100249Q PNR100252Q PNR100253Q PNR100254Q PNR100256Q PNR100259Q PNR100261Q PNR100262Q PNR100263Q PNR100264Q PNR100266Q PNR100267Q PNR100270Q Product UPN/GTIN: 00885074299907 Serial Numbers: PNR419863H Product UPN/GTIN: 00885074300207 Serial Numbers: PNR406072H PNR406348H PNR406416H PNR407438H PNR407439H
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 UPN/GTIN: 00885074300245 Serial Numbers: PNT402938H PNT413911H PNT413995H
If the device loses therapy, it may not be able to treat life-threatening arrhythmias, which could be serious but is not guaranteed to cause immediate harm.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2416-2018 (June 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2416-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.