BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide…
Medical device recall Z-1442-2021. 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-4, REF383564, UDI: 04035479125202 - 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
Affected Serial Number: 60744585 60744586 60744588 60744589 60744590 60744591 60744592 60744593 60744594 60744595 60744596 60744597 60744598 60744599 60744600 60744602 60744603 60744605 60744606 60744607 60744609 60744610 60744611 60744612…
Every code shown here, 1,995 characters
Affected Serial Number: 60744585 60744586 60744588 60744589 60744590 60744591 60744592 60744593 60744594 60744595 60744596 60744597 60744598 60744599 60744600 60744602 60744603 60744605 60744606 60744607 60744609 60744610 60744611 60744612 60744613 60744614 60744735 60744736 60744739 60744740 60744741 60744742 60744744 60744746 60744747 60744748 60744749 60744751 60744752 60744753 60745675 60745676 60745678 60745679 60745680 60745681 60745682 60745895 60745896 60745897 60745898 60745899 60745900 60745901 60745902 60745903 60745905 60745906 60745907 60745912 60745913 60745914 60746065 60746066 60746069 60746070 60746071 60746072 60746073 60746075 60746077 60746079 60746082 60746083 60746084 60747525 60747526 60747529 60747530 60747531 60747532 60747533 60747534 60747535 60747536 60747537 60747538 60747539 60747541 60747542 60747543 60747625 60747628 60747629 60747630 60747631 60747632 60747633 60747634 60747637 60747638 60747639 60747640 60747642 60747644 60747805 60747806 60747808 60747809 60747811 60747812 60747813 60747814 60748467 60748468 60748469 60748471 60748474 60748475 60748476 60748479 60748480 60748483 60748484 60749156 60749157 60749159 60749160 60749161 60749162 60749163 60749168 60749169 60749172 60749315 60749317 60749318 60749319 60749320 60749322 60749324 60750265 60750266 60750267 60750268 60750269 60750270 60750272 60750273 60750274 60750286 60750287 60750288 60750289 60750290 60750292 60750293 60750294 60750295 60750296 60750298 60750299 60750300 60750302 60750303 60750304 60750305 60750306 60750308 60750310 60750311 60750312 60750313 60750314 60750316 60750318 60750322 60750324 60750445 60750446 60750447 60750450 60750451 60750453 60750456 60750457 60750458 60750460 60750461 60750462 60750464 60750885 60750886 60750887 60750890 60750891 60750892 60750894 60750895 60750896 60750897 60750898 60750899 60750900 60750901 60750903 60750904 60750905 60750906 60750907 60750908 60750909 60750910 60750912 60750913 60751724 60751725 60751726 60751727…
FDA’s list runs to 7,781 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 7,781 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.