Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies…
Medical device recall Z-2419-2018. 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
- 8821 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 SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
8821 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product UPN/GTIN: 00885074300252 Serial Numbers: PNT600036S PNT600042S PNT600053S PNT600056S PNT600057S PNT600059S PNT600063S PNT600064S PNT600067S PNT600070S PNT600072S PNT600077S PNT600078S PNT600084S PNT600086S PNT600088S PNT600089S…
Every code shown here, 1,996 characters
Product UPN/GTIN: 00885074300252 Serial Numbers: PNT600036S PNT600042S PNT600053S PNT600056S PNT600057S PNT600059S PNT600063S PNT600064S PNT600067S PNT600070S PNT600072S PNT600077S PNT600078S PNT600084S PNT600086S PNT600088S PNT600089S PNT600090S PNT600093S PNT600094S PNT600097S PNT600100S PNT600101S PNT600102S PNT600103S PNT600104S PNT600105S PNT600107S PNT600108S PNT600109S PNT600111S PNT600113S PNT600115S PNT600118S PNT600119S PNT600135S PNT600157S PNT600159S PNT600160S PNT600161S PNT600167S PNT600169S PNT600171S PNT600177S PNT600179S PNT600180S PNT600181S PNT600182S PNT600183S PNT600184S PNT600185S PNT600186S PNT600187S PNT600188S PNT600189S PNT600192S PNT600193S PNT600194S PNT600195S PNT600198S PNT600201S PNT600202S PNT600203S PNT600205S PNT600207S PNT600209S PNT600210S PNT600211S PNT600212S PNT600213S PNT600216S PNT600217S PNT600218S PNT600219S PNT600220S PNT600221S PNT600223S PNT600225S PNT600226S PNT600227S PNT600228S PNT600229S PNT600230S PNT600231S PNT600232S PNT600233S PNT600234S PNT600235S PNT600238S PNT600239S PNT600241S PNT600242S PNT600243S PNT600244S PNT600245S PNT600246S PNT600247S PNT600248S PNT600249S PNT600250S PNT600251S PNT600252S PNT600253S PNT600254S PNT600255S PNT600256S PNT600257S PNT600267S PNT600278S PNT600281S PNT600316S PNT600317S PNT600337S PNT600349S PNT600365S PNT600369S PNT600377S PNT600392S PNT600393S PNT600394S PNT600395S PNT600396S PNT600397S PNT600398S PNT600399S PNT600400S PNT600402S PNT600403S PNT600404S PNT600405S PNT600412S PNT600416S PNT600417S PNT600429S PNT600433S PNT600436S PNT600438S PNT600440S PNT600443S PNT600448S PNT600449S PNT600454S PNT600457S PNT600460S PNT600462S PNT600463S PNT600465S PNT600466S PNT600483S PNT600489S PNT600521S PNT600539S PNT600540S PNT600544S PNT600545S PNT600547S PNT600550S PNT600558S PNT600559S PNT600560S PNT600561S PNT600567S PNT600568S PNT600576S PNT600577S PNT600580S PNT600581S PNT600584S PNT600592S PNT600593S PNT600594S PNT600595S PNT600596S PNT600597S PNT600598S PNT600600S PNT600601S…
FDA’s list runs to 194,351 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 194,351 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.