BIOTRONIK ITREVIA 7, VR-T DF-1
Medical device recall Z-1451-2021. 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
- 499 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-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
499 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60797220 60797221 60797222 60797223 60797224 60797225 60797226 60797227 60797228 60797230 60797233 60797234 60797235 60797236 60797238 60797239 60797240 60797244 60797245 60798755 60798756 60798757 60798759 60798762 60798764…
Every code shown here, 1,994 characters
Serial Number 60797220 60797221 60797222 60797223 60797224 60797225 60797226 60797227 60797228 60797230 60797233 60797234 60797235 60797236 60797238 60797239 60797240 60797244 60797245 60798755 60798756 60798757 60798759 60798762 60798764 60798765 60798767 60798770 60798773 60798774 60798775 60798776 60798777 60798780 60798785 60798786 60798792 60798793 60798794 60800603 60800604 60800605 60800607 60800613 60800615 60800618 60800731 60800733 60800736 60800737 60800738 60800740 60800742 60800743 60800744 60800745 60800746 60800778 60800782 60800784 60800786 60800790 60800798 60800801 60800802 60800804 60803291 60803293 60803296 60803297 60803301 60803313 60803315 60803326 60803329 60803330 60803332 60803335 60803720 60803721 60803728 60803732 60803733 60803734 60803736 60803737 60803738 60803749 60803750 60803751 60803753 60803754 60803755 60803758 60803762 60803764 60803768 60807835 60807848 60807849 60807868 60807871 60809002 60809004 60809006 60809008 60809012 60809031 60809032 60809036 60809037 60809038 60809039 60809040 60809042 60809043 60809045 60809046 60810246 60810248 60810250 60810252 60810254 60810255 60810257 60810260 60810261 60810262 60810263 60810265 60812205 60812207 60812211 60812215 60812226 60812227 60812229 60812794 60812795 60812797 60812798 60812801 60814326 60814327 60814329 60814331 60814332 60814333 60814334 60814336 60814337 60814339 60814340 60814341 60814342 60815586 60815598 60815599 60815603 60815605 60815606 60815609 60815611 60815614 60816304 60816307 60816308 60816316 60816318 60816319 60816321 60816322 60816788 60816789 60816790 60816793 60816794 60816795 60816796 60816797 60816799 60816800 60816802 60816803 60816804 60816807 60816809 60816812 60816813 60816814 60818665 60818666 60818667 60818668 60818670 60818671 60818676 60818677 60818678 60818683 60818686 60818689 60818691 60818692 60820141 60820142 60820144 60820146 60820147 60820150 60820152 60820161 60821216 60821217 60821228 60822501 60822502 60822504 60822508 60822514…
FDA’s list runs to 4,504 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 4,504 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.