Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The implantable cardioverter defibrillator…
Medical device recall Z-2420-2018. 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
- 5057 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 D144VRC (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.
5057 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product UPN/GTIN: 00613994425027 Serial Numbers: PNT608737S PNT608738S PNT608739S PNT608740S PNT608742S PNT608743S PNT608744S PNT608745S PNT608746S PNT608748S PNT608749S PNT608750S PNT608751S PNT608752S PNT608753S PNT608754S PNT608755S…
Every code shown here, 1,996 characters
Product UPN/GTIN: 00613994425027 Serial Numbers: PNT608737S PNT608738S PNT608739S PNT608740S PNT608742S PNT608743S PNT608744S PNT608745S PNT608746S PNT608748S PNT608749S PNT608750S PNT608751S PNT608752S PNT608753S PNT608754S PNT608755S PNT608756S PNT608757S PNT608758S PNT608759S PNT608760S PNT608761S PNT608762S PNT608763S PNT608764S PNT608765S PNT608766S PNT608767S PNT608768S PNT608769S PNT608770S PNT608771S PNT608772S PNT608773S PNT608774S PNT608775S PNT608776S PNT608777S PNT608778S PNT608779S PNT608780S PNT608781S PNT608782S PNT608783S PNT608784S PNT608785S PNT608786S PNT608787S PNT608788S PNT608789S PNT608790S PNT608791S PNT608792S PNT608793S PNT608794S PNT608795S PNT608796S PNT608798S PNT608799S PNT608800S PNT608801S PNT608802S PNT608803S PNT608804S PNT608805S PNT608806S PNT608807S PNT608808S PNT608809S PNT608810S PNT608830S PNT608924S PNT608926S PNT608927S PNT608930S PNT608931S PNT608932S PNT608934S PNT608938S PNT608939S PNT608940S PNT608944S PNT608945S PNT608946S PNT608947S PNT608948S PNT608949S PNT608951S PNT608952S PNT608953S PNT608954S PNT608955S PNT608956S PNT608957S PNT608958S PNT608959S PNT608960S PNT608961S PNT608962S PNT608963S PNT608964S PNT608965S PNT608966S PNT608967S PNT608968S PNT608969S PNT608970S PNT608971S PNT608972S PNT608973S PNT608974S PNT608975S PNT608976S PNT608977S PNT608978S PNT608979S PNT608980S PNT608981S PNT608982S PNT608983S PNT608984S PNT608985S PNT608986S PNT608987S PNT608988S PNT608989S PNT608990S PNT608991S PNT608992S PNT608993S PNT608994S PNT608995S PNT608996S PNT608997S PNT608998S PNT608999S PNT609000S PNT609001S PNT609073S PNT609074S PNT609075S PNT609076S PNT609077S PNT609078S PNT609079S PNT609081S PNT609082S PNT609083S PNT609115S PNT609116S PNT609117S PNT609118S PNT609119S PNT609120S PNT609121S PNT609122S PNT609123S PNT609124S PNT609125S PNT609127S PNT609128S PNT609129S PNT609130S PNT609131S PNT609132S PNT609133S PNT609134S PNT609135S PNT609137S PNT609138S PNT609139S PNT609140S PNT609141S PNT609142S PNT609143S PNT609144S…
FDA’s list runs to 55,725 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 55,725 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.