BIOTRONIK INVENTRA 7, VR-T DX DF-1
Medical device recall Z-1460-2021. 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
- 285 Unit 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 INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
285 Unit, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60781273 60782345 60782367 60782368 60782370 60782375 60784295 60795401 60795403 60795407 60795413 60799707 60799709 60799710 60799711 60799712 60799715 60799720 60799721 60799723 60799725 60799726 60799727 60799728 60799729…
Every code shown here, 1,994 characters
Serial Number 60781273 60782345 60782367 60782368 60782370 60782375 60784295 60795401 60795403 60795407 60795413 60799707 60799709 60799710 60799711 60799712 60799715 60799720 60799721 60799723 60799725 60799726 60799727 60799728 60799729 60799730 60799731 60799732 60799733 60799734 60799737 60799738 60799740 60799742 60799743 60799744 60799746 60799747 60799748 60799750 60799752 60799753 60799754 60799755 60801025 60801026 60801029 60801031 60801032 60801034 60801035 60801036 60801038 60801039 60801041 60801042 60801043 60801044 60808193 60808204 60808205 60808207 60808208 60808210 60809399 60809400 60809402 60809403 60809407 60809408 60809409 60809414 60809415 60810269 60810276 60810278 60810279 60810280 60810281 60810282 60810283 60810284 60810285 60810286 60810287 60810290 60810291 60810293 60810294 60810295 60811776 60811795 60811796 60811797 60811798 60811801 60811803 60811804 60811805 60811807 60811808 60811810 60811812 60816722 60816724 60816725 60816726 60816728 60816729 60816730 60816731 60816732 60816737 60816740 60816741 60816742 60816743 60816744 60816745 60816746 60816747 60816748 60816750 60816751 60828957 60828958 60828959 60828961 60828963 60828966 60828968 60828969 60828971 60828972 60828973 60828974 60828975 60828976 60829112 60829113 60829114 60829115 60829116 60829118 60829119 60829122 60829123 60829124 60829125 60829126 60829128 60829130 60829134 60829136 60829138 60829139 60829140 60829141 60829142 60829143 60829144 60829145 60829146 60829148 60829149 60829151 60829154 60829155 60829156 60829157 60829158 60829159 60829160 60829161 60832097 60832099 60832103 60832104 60832105 60832108 60832109 60832111 60832372 60832373 60832377 60832378 60832382 60832384 60832386 60832387 60832389 60832392 60832394 60832399 60832404 60832406 60832408 60832410 60832412 60832414 60832415 60832418 60832419 60832426 60832427 60832732 60832735 60832736 60832740 60832743 60832745 60832747 60832750 60832751 60832752 60832753 60832766 60832769 60832770 60832771…
FDA’s list runs to 2,578 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 2,578 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.