BIOTRONIK ITREVIA 7, VR-T DX DF-1
Medical device recall Z-1450-2021. 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
- 386 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 DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
386 UNITS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60819309 60819312 60819314 60819316 60819317 60819332 60819333 60819614 60819616 60819636 60819638 60819640 60819642 60819643 60819646 60819649 60819652 60819655 60819667 60819682 60819948 60819949 60819954 60819955 60819957…
Every code shown here, 1,994 characters
Serial Number 60819309 60819312 60819314 60819316 60819317 60819332 60819333 60819614 60819616 60819636 60819638 60819640 60819642 60819643 60819646 60819649 60819652 60819655 60819667 60819682 60819948 60819949 60819954 60819955 60819957 60819964 60819966 60819967 60820682 60820684 60820687 60820690 60820701 60820702 60820704 60820705 60820708 60820709 60820716 60820717 60820720 60820724 60820725 60820726 60821168 60821170 60821171 60821174 60821183 60821184 60821185 60821191 60821193 60821199 60821206 60821207 60821209 60821212 60822252 60822253 60822255 60822256 60822257 60822259 60822262 60822264 60822267 60822269 60822270 60822273 60822278 60822279 60822281 60822543 60822548 60823564 60823569 60823571 60823575 60823576 60823578 60823580 60823602 60823603 60823605 60823607 60823608 60823611 60823612 60823615 60823616 60823618 60823619 60823623 60823629 60823633 60823636 60823641 60823642 60823643 60823647 60823649 60823650 60823653 60823655 60823656 60823658 60823861 60823864 60823865 60823869 60824283 60824484 60824487 60824489 60824498 60824499 60824501 60824504 60824508 60824519 60824521 60824523 60824524 60824527 60824529 60824532 60824534 60824537 60824539 60824676 60824685 60825001 60825008 60825026 60825039 60825044 60825050 60825054 60825058 60825060 60825692 60825702 60825704 60825713 60825720 60825721 60825724 60825905 60825910 60825917 60825925 60825932 60825933 60825936 60825939 60825940 60826485 60826488 60826503 60826505 60826665 60826669 60826711 60826712 60826890 60827427 60827432 60827438 60827439 60827444 60827445 60827716 60827722 60827726 60827728 60827736 60827743 60827752 60827753 60827758 60827759 60827760 60827879 60827894 60827898 60827900 60827907 60827933 60827934 60827935 60827937 60827940 60827945 60827946 60827947 60827948 60827955 60827960 60827964 60828116 60828130 60828139 60828145 60828159 60828172 60831807 60831814 60831869 60831870 60831885 60831911 60831930 60831938 60831940 60832195 60832197 60832207 60833126 60833698…
FDA’s list runs to 3,487 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 3,487 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.