BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI
Medical device recall Z-1457-2021. 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
- 914 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 DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
914 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60921641 60921645 60921650 60921654 60921661 60921676 60921681 60924487 60924853 60925463 60925466 60925467 60925469 60925472 60927681 60929676 60929681 60929693 60930725 60930727 60930729 60930730 60931822 60931823 60931827…
Every code shown here, 1,994 characters
Serial Number 60921641 60921645 60921650 60921654 60921661 60921676 60921681 60924487 60924853 60925463 60925466 60925467 60925469 60925472 60927681 60929676 60929681 60929693 60930725 60930727 60930729 60930730 60931822 60931823 60931827 60931828 60931832 60931843 60931848 60931851 60932793 60932796 60932825 60932833 60932835 60934488 60934503 60935883 60937416 60937431 60937444 60937446 60937448 60937455 60937459 60937461 60937463 60938681 60938682 60940313 60940320 60940326 60940335 60940914 60943117 60944369 60944385 60944388 60944390 60946404 60946430 60948922 60948927 60948928 60949789 60953224 60953232 60955316 60955320 60957532 60957533 60957983 60957986 60965646 60965647 60966818 60966819 60966828 60967662 60967668 60968092 60968093 60968094 60968100 60975060 60975061 60975077 60975096 60977491 60977507 60977560 60978758 60979333 60979341 60984636 60984641 60984642 60984651 60984665 60985083 60985087 60985094 60985097 60985098 60985099 60985100 60985101 60985103 60986653 60986656 60986679 60988512 60988526 60988528 60988545 60988546 60989796 60989807 60989817 60989820 60990218 60990220 60990225 60990227 60990230 60990233 60990238 60990243 60990244 60990245 60990247 60990253 60990256 60992012 60992013 60992023 60992024 60992025 60992027 60992031 60992036 60995464 60995466 60995469 60997627 60997634 60997683 60997686 60997691 60997692 60997708 60998320 60998321 60998322 60998327 60998338 60998350 60998355 60998699 60998701 60998706 60998712 60998721 60998747 60998748 60999570 60999579 60999583 61000509 61000511 61000514 61000523 61001685 61001688 61001690 61001691 61001692 61001709 61001716 61003225 61003231 61008758 61008772 61008776 61010230 61010254 61010255 61010311 61010349 61010351 61010361 61010368 61010369 61011109 61011126 61011562 61011571 61011588 61011600 61012149 61012169 61012171 61012173 61013677 61013679 61013684 61013687 61013688 61013692 61013693 61013706 61013708 61013730 61014418 61014463 61014493 61014499 61014500 61014502 61014506…
FDA’s list runs to 8,239 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 8,239 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.