BIOTRONIK Ilestro 7 VR-T, DF-1
Medical device recall Z-1443-2021. 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
- 1000 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, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
1000 UNITS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60713356 60713357 60713358 60713359 60713360 60713361 60713362 60713363 60713364 60713365 60715282 60715285 60715286 60715287 60715288 60715292 60715293 60715296 60715299 60715300 60715301 60716193 60716194 60716195 60716196…
Every code shown here, 1,994 characters
Serial Number 60713356 60713357 60713358 60713359 60713360 60713361 60713362 60713363 60713364 60713365 60715282 60715285 60715286 60715287 60715288 60715292 60715293 60715296 60715299 60715300 60715301 60716193 60716194 60716195 60716196 60716197 60716198 60716199 60716201 60716203 60716204 60716205 60716208 60716210 60716597 60716598 60716599 60716600 60716603 60716604 60716606 60716608 60716611 60716612 60716613 60716615 60716616 60716647 60716648 60716651 60716652 60716653 60716654 60716655 60716656 60717982 60717984 60717985 60717988 60717989 60717994 60717995 60717996 60717998 60717999 60718001 60718002 60718003 60718004 60718005 60718006 60718007 60718008 60718010 60718013 60718014 60718015 60718017 60718020 60718024 60718026 60718027 60718028 60718030 60718031 60718032 60718033 60718035 60718039 60718043 60718044 60718045 60718046 60718048 60718054 60718055 60718059 60718061 60718067 60718957 60718958 60718959 60718961 60718963 60718966 60718967 60718969 60718970 60718971 60718972 60718973 60718974 60718976 60718977 60718978 60718980 60718984 60718987 60718988 60718989 60718990 60718991 60718992 60718993 60718994 60718996 60718999 60719000 60719001 60719003 60719700 60719701 60719702 60719704 60719707 60719710 60719719 60719720 60719721 60719726 60719729 60719736 60721875 60721880 60721881 60721885 60721886 60721893 60721895 60721896 60721899 60721900 60721901 60721902 60721904 60721905 60722827 60722828 60722830 60722834 60722835 60722836 60722837 60722838 60722840 60722841 60722842 60722843 60722844 60722846 60725187 60725191 60725859 60725862 60725864 60725870 60725873 60725884 60725890 60725891 60725893 60725895 60725906 60726586 60726600 60728581 60728582 60728583 60728599 60728600 60728602 60728603 60728604 60728605 60728606 60728607 60728610 60728611 60728613 60728614 60728618 60729349 60729350 60729352 60729356 60729357 60729358 60729360 60729370 60729372 60729374 60729375 60729376 60729377 60729620 60729621 60729622 60729623 60729624 60729626…
FDA’s list runs to 9,013 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 9,013 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.