BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI
Medical device recall Z-1456-2021. 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
- 3497 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 ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
3497 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60916214 60916993 60917005 60917012 60917120 60917122 60917132 60919194 60919199 60919356 60919358 60919896 60919903 60919907 60921836 60921843 60921850 60921860 60921869 60921870 60921871 60921881 60921886 60921896 60922662…
Every code shown here, 1,994 characters
Serial Number 60916214 60916993 60917005 60917012 60917120 60917122 60917132 60919194 60919199 60919356 60919358 60919896 60919903 60919907 60921836 60921843 60921850 60921860 60921869 60921870 60921871 60921881 60921886 60921896 60922662 60922664 60922685 60922713 60922714 60922715 60922717 60922720 60922724 60922727 60923062 60923078 60923082 60923111 60923113 60923114 60923115 60923119 60923262 60923268 60923275 60923279 60924561 60924569 60924575 60924581 60924592 60924610 60924613 60924614 60924683 60924836 60924840 60924841 60924843 60924846 60925361 60925362 60925364 60925368 60925382 60925383 60925406 60925408 60925409 60925413 60925419 60925421 60925810 60925816 60926798 60926800 60926806 60926807 60926808 60926809 60926811 60926813 60926820 60926821 60926823 60926825 60926828 60926829 60926830 60927167 60927169 60927171 60927175 60927176 60927178 60927183 60927186 60927187 60927188 60927199 60927203 60927204 60927208 60927209 60928384 60928386 60928388 60928390 60928393 60928396 60928399 60928406 60928413 60928419 60928420 60928434 60928438 60928440 60928450 60929725 60929726 60929728 60929734 60929736 60929737 60929738 60929741 60929748 60929753 60930528 60930533 60930541 60930545 60930550 60930551 60930554 60931087 60931088 60931097 60931104 60931112 60931129 60931133 60931134 60932969 60932973 60932978 60933020 60933025 60933088 60933090 60933096 60933104 60933516 60933517 60933526 60933537 60933545 60933557 60934456 60934459 60934462 60934480 60934812 60934813 60934825 60934834 60934838 60934846 60934850 60934852 60935985 60935986 60935992 60935994 60936021 60936022 60936041 60936042 60936045 60936050 60936056 60936288 60936292 60936304 60936315 60936329 60937092 60937107 60937281 60937293 60937299 60937304 60937314 60937315 60937319 60937333 60937549 60937552 60937554 60937907 60938344 60938345 60938346 60938352 60938361 60938371 60938382 60938385 60938390 60938408 60938417 60939305 60939309 60939315 60939319 60939322 60939323 60939325 60939332…
FDA’s list runs to 31,487 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 31,487 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.