BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI
Medical device recall Z-1458-2021. 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
- 779 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, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
779 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60921514 60921555 60922407 60922410 60922422 60922436 60922438 60922439 60922791 60922792 60922793 60923703 60923724 60923740 60925141 60925169 60925173 60925178 60925184 60925499 60927059 60927066 60927075 60927476 60927478…
Every code shown here, 1,994 characters
Serial Number 60921514 60921555 60922407 60922410 60922422 60922436 60922438 60922439 60922791 60922792 60922793 60923703 60923724 60923740 60925141 60925169 60925173 60925178 60925184 60925499 60927059 60927066 60927075 60927476 60927478 60927479 60927481 60927491 60927494 60927499 60928721 60928723 60928725 60928726 60928728 60928730 60928773 60928780 60928852 60930277 60930279 60930281 60930284 60930288 60930294 60930300 60930301 60930304 60930305 60930310 60930313 60930314 60930319 60930326 60931702 60931705 60931709 60931710 60931711 60931712 60931731 60931736 60933207 60933208 60933212 60933213 60933216 60933565 60933568 60933575 60933601 60933602 60933607 60934013 60934015 60934019 60934021 60934030 60934034 60934037 60934038 60934673 60934687 60934709 60935497 60935540 60938587 60938593 60938595 60938600 60938622 60938624 60938629 60938635 60938646 60938653 60939568 60939577 60939581 60939583 60939584 60939585 60939587 60939599 60939601 60939602 60939603 60939607 60939608 60939611 60939619 60939620 60939622 60939626 60939668 60939669 60939670 60939679 60941089 60941312 60941318 60941320 60941325 60942677 60942711 60943546 60943547 60943574 60943575 60943576 60943582 60943583 60943588 60944156 60944160 60944169 60944183 60944193 60944194 60945717 60946213 60946217 60946238 60946242 60946250 60946276 60946278 60946281 60946285 60946287 60946295 60947426 60947429 60947434 60949319 60950160 60950286 60950287 60950291 60950292 60950293 60951417 60951430 60951432 60951440 60953881 60954792 60954796 60954818 60954823 60955013 60955491 60955492 60959147 60959439 60962883 60962891 60962893 60965719 60965757 60966018 60966023 60966579 60971911 60971918 60971937 60971941 60971951 60971962 60974033 60974059 60974063 60974069 60975139 60975155 60975167 60975173 60975316 60976019 60976156 60976904 60976925 60977964 60977984 60977986 60978952 60978993 60978995 60979034 60979036 60979617 60979623 60979633 60980152 60982207 60982500 60982501 60982505 60982509 60983519…
FDA’s list runs to 7,024 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 7,024 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.