Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154ATG Pr

Is my product affected?

Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias.

• UPC 00613994170927
• UPC 00885074299938
• UPC 00885074300191

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling approximately 8,890 EnTrust Dual Chamber implantable cardioverter defibrillators (ICDs) due to a potential safety issue. The devices may experience loss of high voltage and anti-tachycardia pacing therapy as their batteries approach end-of-life. Specifically, under certain circumstances, the device may jump directly to an End of Life alert without first displaying a replacement indicator alert, and the remaining battery may not have enough capacity to properly charge the high voltage circuits needed to deliver therapy.

The recalled devices are identified by specific serial numbers beginning with "PNR" and have been distributed worldwide, including throughout the United States. The record does not specify what action affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: Worldwide Distribution - US Nationwide Quantity: 8890 units Lot/code info: Product UPN/GTIN: 00613994170927 Serial Numbers: PNR606917S PNR606918S PNR606923S Product UPN/GTIN: 00885074299938 Serial Numbers: PNR414990H PNR417905H PNR600110S PNR600121S PNR600123S PNR600136S PNR600141S PNR600147S PNR600148S PNR600157S PNR600163S PNR600166S PNR600176S PNR600177S PNR600183S PNR600189S PNR600190S PNR600192S PNR600194S PNR600195S PNR600198S PNR600203S PNR600290S PNR600306S PNR600381S PNR600382S PNR600383S PNR600385S PNR600387S PNR600388S PNR600389S PNR600390S PNR600392S PNR600393S PNR600396S PNR600397S PNR600398S PNR600401S PNR600402S PNR600404S PNR600405S PNR600406S PNR600407S PNR600409S PNR600410S PNR600412S PNR600415S PNR600416S PNR600417S PNR600418S PNR600419S PNR600422S PNR600423S PNR600424S PNR600425S PNR600426S PNR600427S PNR600428S PNR600429S PNR600432S PNR600433S PNR600434S PNR600435S PNR600436S PNR600437S PNR600438S PNR600439S PNR600441S PNR600442S PNR600443S PNR600448S PNR600450S PNR600452S PNR600453S PNR600454S PNR600455S PNR600458S PNR600459S PNR600461S PNR600462S PNR600463S PNR600464S PNR600503S PNR600504S PNR600505S PNR600506S PNR600510S PNR600511S PNR600545S PNR600548S PNR600549S PNR600551S PNR600552S PNR600553S PNR600554S PNR600555S PNR600557S PNR600561S PNR600562S PNR600563S PNR600564S PNR600565S PNR600566S PNR600570S PNR600572S PNR600576S PNR600577S PNR600578S PNR600581S PNR600583S PNR600585S PNR600599S PNR600600S PNR600601S PNR600603S PNR600604S PNR600609S PNR600610S PNR600614S PNR600615S PNR600616S PNR600619S PNR600620S PNR600621S PNR60

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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