Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies…
Medical device recall Z-2417-2018. Published in FDA’s Enforcement Report on Jul 18, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 18, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 8890 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.
8890 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product UPN/GTIN: 00613994170927 Serial Numbers: PNR606917S PNR606918S PNR606923S Product UPN/GTIN: 00885074299938 Serial Numbers: PNR414990H PNR417905H PNR600110S PNR600121S PNR600123S PNR600136S PNR600141S PNR600147S PNR600148S…
Every code shown here, 1,990 characters
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 PNR600623S PNR600624S PNR600626S PNR600629S PNR600631S PNR600731S PNR600733S PNR600770S PNR600773S PNR600775S PNR600781S PNR600784S PNR600786S PNR600789S PNR600790S PNR600792S PNR600798S PNR600801S PNR600802S PNR600804S PNR600811S PNR600813S PNR600816S PNR600818S PNR600819S PNR600821S PNR600824S PNR600849S PNR600886S PNR600887S PNR600891S PNR600892S PNR600904S PNR600933S PNR600948S PNR600949S PNR600950S PNR600953S PNR600956S PNR600957S PNR600958S PNR600964S PNR600978S PNR600979S PNR600987S…
FDA’s list runs to 104,263 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Nationwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 21, 2018.
- FDA classified it on Jul 10, 2018.
- FDA’s Enforcement Report published it on Jul 18, 2018.
- FDA terminated it on Jun 16, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), of Mounds View, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 104,263 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.