Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator…
Medical device recall Z-2421-2018. 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
- 1867 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 Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
1867 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product UPN/GTIN: 00613994425010 Serial Numbers: PNR611652S PNR611653S PNR611654S PNR611655S PNR611656S PNR611657S PNR611658S PNR611659S PNR611661S PNR611662S PNR611663S PNR611664S PNR611665S PNR611666S PNR611667S PNR611669S PNR611670S…
Every code shown here, 1,996 characters
Product UPN/GTIN: 00613994425010 Serial Numbers: PNR611652S PNR611653S PNR611654S PNR611655S PNR611656S PNR611657S PNR611658S PNR611659S PNR611661S PNR611662S PNR611663S PNR611664S PNR611665S PNR611666S PNR611667S PNR611669S PNR611670S PNR611671S PNR611672S PNR611673S PNR611674S PNR611675S PNR611724S PNR611726S PNR611728S PNR611730S PNR611734S PNR611735S PNR611738S PNR611743S PNR611746S PNR611749S PNR611750S PNR611751S PNR611752S PNR611753S PNR611754S PNR611755S PNR611756S PNR611757S PNR611758S PNR611759S PNR611761S PNR611762S PNR611763S PNR611764S PNR611765S PNR611767S PNR611768S PNR611861S PNR611862S PNR611863S PNR611864S PNR611865S PNR611866S PNR611867S PNR611868S PNR611869S PNR611870S PNR611871S PNR611872S PNR611873S PNR611875S PNR611876S PNR611877S PNR611878S PNR611879S PNR611880S PNR611881S PNR611883S PNR611884S PNR611885S PNR611886S PNR611888S PNR611889S PNR611891S PNR611892S PNR611893S PNR611894S PNR611895S PNR611896S PNR611897S PNR611898S PNR611899S PNR611900S PNR611901S PNR611902S PNR611903S PNR611904S PNR611905S PNR611909S PNR611916S PNR611917S PNR611929S PNR611930S PNR611931S PNR611933S PNR611934S PNR611936S PNR611937S PNR611938S PNR611939S PNR611940S PNR611941S PNR611943S PNR611944S PNR611945S PNR611947S PNR611948S PNR611955S PNR611956S PNR611957S PNR611958S PNR611959S PNR611961S PNR611962S PNR611964S PNR611978S PNR611979S PNR611980S PNR611981S PNR611982S PNR611983S PNR611984S PNR611985S PNR611986S PNR611987S PNR611988S PNR611989S PNR611990S PNR611991S PNR611992S PNR611994S PNR611995S PNR611997S PNR611998S PNR611999S PNR612000S PNR612003S PNR612004S PNR612005S PNR612006S PNR612007S PNR612008S PNR612009S PNR612010S PNR612011S PNR612012S PNR612013S PNR612014S PNR612015S PNR612016S PNR612017S PNR612018S PNR612019S PNR612020S PNR612021S PNR612022S PNR612023S PNR612024S PNR612025S PNR612026S PNR612027S PNR612028S PNR612029S PNR612030S PNR612031S PNR612032S PNR612033S PNR612034S PNR612036S PNR612037S PNR612038S PNR612039S PNR612040S PNR612042S PNR612043S…
FDA’s list runs to 20,585 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 20,585 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.