BIOTRONIK ITREVIA 7, DR-T QP DF-1
Medical device recall Z-1455-2021. 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
- 658 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, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
658 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60819315 60819319 60819321 60819324 60819326 60819337 60819609 60819617 60819619 60819625 60819626 60819637 60819639 60819659 60819677 60819680 60819683 60819684 60820683 60820689 60820691 60820692 60820696 60820698 60820700…
Every code shown here, 1,994 characters
Serial Number 60819315 60819319 60819321 60819324 60819326 60819337 60819609 60819617 60819619 60819625 60819626 60819637 60819639 60819659 60819677 60819680 60819683 60819684 60820683 60820689 60820691 60820692 60820696 60820698 60820700 60820703 60820706 60820721 60821166 60821204 60823863 60826469 60826472 60826478 60826482 60826489 60826656 60826663 60826708 60826730 60826897 60829520 60829533 60829573 60829578 60829579 60831611 60831613 60831616 60831628 60831629 60831631 60831634 60831636 60831877 60831922 60832196 60833111 60833121 60833124 60833127 60833131 60833132 60833137 60833139 60833142 60833145 60833147 60833158 60833680 60833685 60833693 60833694 60833716 60834154 60834158 60834164 60835646 60837393 60837396 60837420 60838766 60838767 60838770 60838853 60838855 60840023 60840027 60840043 60840047 60840462 60840476 60840478 60840579 60869561 60870362 60870364 60870755 60870756 60870757 60870758 60870761 60870771 60870772 60870775 60870783 60870787 60871014 60871016 60871017 60871023 60871025 60871413 60871415 60871416 60871431 60871432 60871631 60871638 60871640 60871643 60872561 60872565 60872573 60872576 60872579 60872580 60872581 60872582 60872857 60872871 60872872 60872874 60879612 60879614 60879616 60879617 60879630 60879632 60879633 60879634 60879639 60879642 60879651 60879663 60879666 60879667 60879674 60879677 60879697 60879712 60879714 60879718 60879720 60879848 60880034 60880041 60880713 60880761 60880766 60880778 60880921 60880925 60881932 60885527 60885735 60885737 60885738 60885743 60886341 60886348 60886362 60896489 60899144 60899181 60899213 60899268 60899294 60899917 60899939 60900316 60900328 60900670 60900671 60900675 60901830 60901832 60901866 60901881 60901887 60902149 60902156 60902162 60902163 60902174 60902179 60902194 60902199 60902204 60902209 60902210 60902215 60902218 60902907 60902935 60902946 60903066 60903398 60903401 60903405 60903408 60903409 60903410 60903413 60903415 60904610 60904611 60904614 60904618 60904625…
FDA’s list runs to 5,935 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 5,935 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.