BIOTRONIK ITREVIA 7, VR-T DF-4
Medical device recall Z-1452-2021. 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
- 670 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 ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
670 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60758873 60790507 60790508 60790509 60793100 60793104 60793112 60793113 60793114 60793115 60793120 60793132 60793151 60793446 60793447 60797807 60797810 60797811 60797813 60797818 60797820 60797824 60797825 60797829 60797832…
Every code shown here, 1,994 characters
Serial Number 60758873 60790507 60790508 60790509 60793100 60793104 60793112 60793113 60793114 60793115 60793120 60793132 60793151 60793446 60793447 60797807 60797810 60797811 60797813 60797818 60797820 60797824 60797825 60797829 60797832 60797833 60797835 60797838 60797840 60797841 60797842 60797853 60797854 60797856 60798617 60798618 60798620 60798633 60798637 60798641 60799910 60799917 60799921 60799924 60799925 60799926 60799929 60799935 60799937 60799938 60799947 60800996 60800998 60802135 60802141 60802144 60802568 60802575 60802579 60805453 60805593 60806318 60806320 60807087 60807090 60807091 60807092 60807093 60807095 60807096 60807186 60807187 60807189 60807198 60807199 60807203 60808405 60808407 60808412 60808413 60808416 60808426 60808428 60808430 60808432 60808433 60808436 60810738 60810741 60810742 60810744 60810747 60810748 60810750 60810753 60810755 60810758 60810759 60810762 60810765 60810766 60810767 60810770 60810774 60810776 60811841 60811842 60811850 60811982 60811983 60811985 60811990 60811999 60812000 60812002 60812003 60812009 60812016 60812018 60812683 60812686 60812688 60812697 60812701 60812775 60812777 60812779 60812785 60812791 60813683 60813684 60813685 60813690 60813691 60813692 60813693 60813694 60813695 60813696 60813698 60813700 60813701 60814174 60814175 60814178 60814180 60814182 60814184 60814186 60814189 60814190 60814195 60814819 60814822 60814835 60814840 60814841 60814843 60814844 60814845 60814848 60814849 60814852 60814854 60815356 60815357 60815359 60815361 60815363 60815365 60815366 60819234 60819240 60819259 60819260 60820995 60820996 60820998 60820999 60821003 60821005 60821006 60821011 60821014 60821017 60821020 60821027 60821030 60821031 60821032 60821033 60821034 60821035 60821038 60821039 60821040 60821042 60821043 60821046 60821247 60821248 60821250 60821256 60822034 60822039 60822043 60822307 60822311 60822314 60822329 60823021 60823030 60823031 60823033 60823037 60823055 60823057 60823071 60823072 60823073…
FDA’s list runs to 6,043 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 6,043 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.