BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide…
Medical device recall Z-1441-2021. 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.
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 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
serial numbers: 60705317 60707977 60708912 60709157 60709393 60709408 60709992 60710002 60710004 60710006 60710009 60710010 60710202 60710203 60711081 60711093 60711108 60711123 60711124 60711130 60711285 60711293 60711297 60711301…
Every code shown here, 1,996 characters
serial numbers: 60705317 60707977 60708912 60709157 60709393 60709408 60709992 60710002 60710004 60710006 60710009 60710010 60710202 60710203 60711081 60711093 60711108 60711123 60711124 60711130 60711285 60711293 60711297 60711301 60711624 60711628 60711633 60711641 60711653 60711655 60711656 60711658 60711659 60711660 60711661 60712136 60712137 60712142 60712164 60712165 60712171 60712212 60712362 60712364 60712366 60712381 60712433 60712434 60712440 60712453 60712454 60712455 60712456 60712632 60712635 60712662 60712667 60712668 60712677 60712678 60712679 60712680 60712681 60712683 60712688 60712690 60713619 60713623 60713624 60713625 60713626 60713628 60713629 60713630 60713631 60713877 60713878 60713879 60713881 60713882 60713883 60713887 60713891 60713894 60713899 60713906 60713907 60713908 60713910 60713911 60713913 60713917 60713922 60713928 60713929 60713935 60713939 60713940 60713941 60713945 60713947 60713949 60713956 60713957 60713958 60713960 60713961 60713962 60713964 60713965 60713966 60713968 60713969 60713971 60713975 60713976 60713977 60713978 60713983 60713984 60713990 60713991 60713992 60713993 60713994 60713995 60714192 60714193 60714195 60714196 60714198 60714200 60714201 60714202 60714203 60714204 60714206 60714209 60714210 60714212 60714215 60714217 60714221 60714223 60714226 60714227 60714232 60714233 60714235 60714237 60714240 60714241 60714244 60714245 60714249 60714250 60714586 60714587 60714592 60714594 60714599 60714601 60714602 60714605 60714608 60714610 60714772 60714773 60714774 60714776 60714777 60714787 60714790 60714791 60714793 60714796 60714801 60714893 60714894 60714896 60714897 60714899 60714900 60714902 60714903 60714905 60714907 60714908 60714911 60714915 60714919 60714924 60714927 60714929 60714931 60714936 60714941 60714942 60714946 60714948 60714951 60714957 60714964 60714965 60714966 60714969 60714970 60715193 60715202 60715204 60715205 60715214 60715215 60715216 60715217 60715218 60715219 60715220 60715221 60715223…
FDA’s list runs to 23,028 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 23,028 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.