BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI
Medical device recall Z-1459-2021. 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.
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 ProMRI, REF 399436, UDI: 04035479136314 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60934351 60829152 60832096 60832371 60832379 60832390 60832402 60832413 60832416 60832741 60832748 60832754 60832761 60832763 60832880 60832889 60832910 60832928 60834412 60834435 60836055 60836063 60837602 60839079 60839092…
Every code shown here, 1,994 characters
Serial Number 60934351 60829152 60832096 60832371 60832379 60832390 60832402 60832413 60832416 60832741 60832748 60832754 60832761 60832763 60832880 60832889 60832910 60832928 60834412 60834435 60836055 60836063 60837602 60839079 60839092 60839097 60851001 60852519 60852527 60853576 60853580 60854501 60855490 60855495 60855499 60857084 60857085 60857086 60857087 60857103 60857710 60857718 60857721 60857789 60858453 60858457 60858460 60858466 60858468 60858472 60858477 60858480 60858481 60858483 60859370 60859372 60859378 60859380 60859388 60859392 60859395 60859409 60859413 60859417 60860802 60860804 60860808 60861046 60861047 60861052 60861176 60861177 60861179 60861180 60861182 60861188 60861191 60861242 60861243 60861247 60861248 60861252 60861259 60861271 60861289 60861290 60861292 60861294 60861297 60861298 60861299 60861300 60861303 60861323 60861326 60861329 60861330 60861337 60861338 60861340 60862440 60862446 60862449 60862450 60862453 60862455 60862456 60864219 60864221 60864222 60864225 60864226 60864227 60864229 60864230 60864233 60864235 60864236 60864237 60864238 60864240 60864242 60864247 60865643 60865647 60865648 60865649 60865656 60865658 60865659 60866272 60866277 60866283 60866285 60866287 60866288 60866289 60866290 60868042 60868043 60868045 60868046 60868047 60868048 60868053 60868054 60868056 60868057 60868059 60868060 60868061 60868063 60868064 60868065 60868066 60868067 60869024 60869025 60869028 60869033 60869039 60869043 60869046 60869048 60869050 60870054 60870057 60870058 60870060 60870061 60870062 60870063 60870064 60870066 60870068 60870070 60870725 60870726 60870728 60870729 60870730 60870732 60870733 60870735 60870737 60870738 60870740 60870741 60870742 60870745 60870746 60870748 60870752 60871981 60871983 60871984 60871989 60871991 60871992 60871995 60871996 60871997 60871998 60871999 60872000 60872001 60872003 60872004 60872005 60872006 60872008 60872009 60872917 60872920 60872921 60872922 60872923 60872928 60872929 60872930…
FDA’s list runs to 39,866 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 39,866 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.