BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI
Medical device recall Z-1461-2021. 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
- 1547 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 DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
1547 UNITS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 61009745 61031041 61031948 61035465 61035477 61036566 61037118 61037352 61037354 61037367 61037371 61037377 61037383 61037384 61037386 61037393 61037940 61037953 61037966 61038664 61038665 61038672 61038679 61038700 61038701…
Every code shown here, 1,994 characters
Serial Number 61009745 61031041 61031948 61035465 61035477 61036566 61037118 61037352 61037354 61037367 61037371 61037377 61037383 61037384 61037386 61037393 61037940 61037953 61037966 61038664 61038665 61038672 61038679 61038700 61038701 61038705 61038709 61038710 61038711 61038715 61038720 61038722 61038731 61038732 61038905 61038929 61039138 61039376 61039377 61039381 61039384 61039385 61039388 61039393 61040798 61040953 61040966 61040978 61040988 61040992 61041010 61041405 61041407 61041495 61041500 61041509 61041543 61041560 61041569 61041572 61041588 61041590 61041830 61041834 61041852 61041855 61042207 61042208 61042219 61042260 61042267 61042320 61042330 61042343 61042928 61042942 61042944 61042965 61043039 61043075 61043283 61043551 61044057 61044061 61044100 61044246 61044258 61044262 61044279 61044280 61044284 61044285 61044286 61044288 61044305 61044306 61044312 61044318 61044324 61044325 61044330 61044336 61044338 61044341 61044485 61044491 61044505 61044605 61044609 61044611 61044613 61044615 61044618 61044622 61044629 61044630 61044644 61044649 61044650 61044655 61044901 61044905 61044906 61044914 61044925 61045369 61045379 61045406 61045424 61045714 61045724 61045735 61045756 61045761 61046127 61046339 61046340 61046345 61046354 61046517 61046532 61046601 61046609 61046619 61046623 61046631 61046635 61047131 61047153 61047154 61047163 61047170 61047355 61047358 61047382 61047383 61047612 61047613 61047614 61047620 61047621 61047622 61047626 61047627 61047629 61047631 61047633 61047634 61047640 61047941 61047945 61047953 61047962 61048650 61048652 61048654 61048657 61048665 61048668 61048669 61048679 61048680 61048684 61048689 61048690 61048700 61048703 61048956 61048963 61048990 61048996 61049000 61049016 61049349 61049351 61049355 61049368 61049373 61049374 61049378 61049385 61049397 61049400 61049405 61049424 61049425 61049431 61049546 61049547 61049553 61049556 61049560 61049563 61049565 61050350 61050360 61050362 61050367 61050368 61050371…
FDA’s list runs to 13,936 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 13,936 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
-
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.