BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI
Medical device recall Z-1446-2021. 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
- 1652 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 Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
1652 UNITS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60824474 60824475 60824491 60824629 60824642 60824679 60825002 60825013 60825017 60825022 60825023 60825049 60825055 60825699 60825703 60825709 60825717 60825726 60825729 60825734 60825740 60825901 60825906 60825926 60825945…
Every code shown here, 1,994 characters
Serial Number 60824474 60824475 60824491 60824629 60824642 60824679 60825002 60825013 60825017 60825022 60825023 60825049 60825055 60825699 60825703 60825709 60825717 60825726 60825729 60825734 60825740 60825901 60825906 60825926 60825945 60826501 60826504 60826652 60826660 60826693 60826699 60826716 60826726 60826735 60831890 60833123 60833702 60834136 60834474 60834512 60834525 60834535 60834869 60835629 60835640 60835650 60835657 60835662 60835664 60835668 60835978 60835998 60836218 60837185 60837193 60837213 60837218 60837233 60837422 60837427 60837832 60838223 60838230 60838468 60838496 60838499 60838865 60838866 60838870 60840477 60840585 60840833 60840835 60840836 60840837 60840839 60840840 60840904 60841110 60841125 60841445 60841452 60841459 60841461 60842559 60843499 60843500 60843793 60843804 60843813 60843814 60843818 60843825 60843838 60843912 60843920 60843925 60844777 60844780 60844781 60844790 60844793 60844797 60844798 60844800 60845037 60845052 60845057 60845074 60845896 60845903 60845905 60845909 60845910 60845920 60845931 60845940 60845941 60845943 60846819 60846820 60846827 60846832 60847563 60847567 60847569 60847715 60847716 60847718 60847720 60847721 60847724 60848562 60848564 60848592 60848593 60848595 60849559 60851142 60852031 60852569 60852570 60852576 60852580 60852588 60853095 60854784 60855093 60855095 60855142 60855153 60855157 60855158 60855414 60855990 60856447 60856456 60856464 60856710 60856711 60856720 60856724 60856725 60856728 60856745 60857143 60859552 60860702 60860904 60860912 60861452 60861806 60861816 60861843 60862027 60862058 60862060 60862063 60862266 60862515 60862528 60863855 60863857 60863858 60863860 60863872 60863873 60863947 60863974 60863979 60863980 60864460 60864461 60864464 60864466 60864469 60864471 60864476 60864511 60864738 60864772 60864780 60864791 60864793 60864798 60864801 60864804 60864878 60864903 60865220 60865225 60869562 60869567 60870347 60870355 60870357 60870360 60870361 60870363 60870366…
FDA’s list runs to 14,881 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 14,881 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.