BIOTRONIK Ilestro 7 VR-T DX, DF-1
Medical device recall Z-1445-2021. Published in FDA’s Enforcement Report on Apr 28, 2021.
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 Apr 28, 2021. 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
- 3664 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?
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT’Ds)
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
3664 UNITS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60703003 60703353 60703354 60703936 60703940 60703948 60704288 60704291 60704298 60704306 60704307 60704309 60704315 60704503 60704504 60704509 60704510 60704517 60704519 60704522 60704756 60704759 60704763 60704765 60704767…
Every code shown here, 1,994 characters
Serial Number 60703003 60703353 60703354 60703936 60703940 60703948 60704288 60704291 60704298 60704306 60704307 60704309 60704315 60704503 60704504 60704509 60704510 60704517 60704519 60704522 60704756 60704759 60704763 60704765 60704767 60704768 60704772 60704774 60705316 60705327 60705329 60705330 60705334 60705338 60705340 60705345 60705367 60705368 60705370 60705371 60705642 60705649 60705652 60705666 60705670 60705676 60705707 60705715 60706224 60706232 60706233 60707048 60707052 60707053 60707054 60707060 60707063 60707064 60707065 60707066 60707067 60707070 60707072 60707073 60707074 60707076 60707079 60707085 60707089 60707090 60707091 60707092 60707097 60707098 60707099 60707101 60707105 60707106 60707107 60707109 60707110 60707112 60707960 60707965 60707966 60707967 60707969 60707970 60707972 60707976 60707978 60707980 60707982 60707983 60707984 60707985 60707990 60707993 60707995 60707998 60708002 60708003 60708005 60708006 60708009 60708011 60708012 60708014 60708016 60708017 60708020 60708021 60708025 60708029 60708194 60708195 60708197 60708200 60708203 60708205 60708208 60708209 60708686 60708687 60708690 60708692 60708693 60708696 60708697 60708699 60708700 60708702 60708703 60708705 60708706 60708709 60708711 60708712 60708714 60708715 60708883 60708884 60708885 60708886 60708887 60708888 60708889 60708890 60708891 60708899 60708900 60708901 60708903 60708904 60708905 60708906 60708907 60708909 60708910 60708911 60708920 60708921 60709123 60709124 60709125 60709127 60709128 60709130 60709131 60709135 60709140 60709142 60709144 60709145 60709146 60709147 60709148 60709150 60709151 60709156 60709159 60709160 60709161 60709372 60709375 60709376 60709378 60709381 60709384 60709385 60709388 60709391 60709395 60709396 60709398 60709401 60709402 60709403 60709404 60709406 60709407 60709409 60709410 60709993 60709994 60709995 60710003 60710007 60710012 60710013 60710016 60710017 60710018 60710019 60710020 60710021 60710022 60710024 60710025 60710027…
FDA’s list runs to 32,990 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.
US: Nationwide OUS: Worldwide
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 Mar 8, 2021.
- FDA classified it on Apr 21, 2021.
- FDA’s Enforcement Report published it on Apr 28, 2021.
- FDA terminated it on Apr 25, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- BIOTRONIK Inc, of Lake Oswego, OR.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
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 32,990 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
-
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.