BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage: intended to provide…
Medical device recall Z-1447-2021. 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
- 1176 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 Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
1176 UNITS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60724952 60725626 60726518 60726521 60726884 60726900 60727195 60727216 60727250 60727384 60727392 60727796 60728040 60728052 60728058 60728799 60728800 60728805 60728807 60728822 60728826 60728827 60728828 60728837 60728847…
Every code shown here, 1,994 characters
Serial Number 60724952 60725626 60726518 60726521 60726884 60726900 60727195 60727216 60727250 60727384 60727392 60727796 60728040 60728052 60728058 60728799 60728800 60728805 60728807 60728822 60728826 60728827 60728828 60728837 60728847 60728858 60728881 60728914 60728920 60728938 60729002 60729005 60729018 60729040 60729048 60729055 60729058 60729079 60729086 60729127 60729789 60729791 60729793 60729797 60729803 60729807 60729808 60729816 60730309 60730311 60730313 60730316 60730319 60730330 60730335 60730357 60731398 60731400 60731414 60731415 60737615 60740183 60740279 60740282 60740528 60740537 60740538 60740539 60740543 60740565 60740566 60740567 60740571 60740573 60740574 60740586 60740687 60740720 60740972 60740977 60740978 60740993 60741021 60741025 60741026 60741049 60741298 60741301 60741317 60741320 60741333 60741343 60741619 60741740 60741747 60741762 60741768 60741771 60741772 60741787 60741792 60741802 60741804 60741813 60741818 60744247 60744249 60744253 60744254 60744257 60744262 60744264 60744290 60744291 60744305 60744309 60744310 60744315 60744317 60744324 60744915 60744917 60744920 60744922 60744923 60744925 60744929 60744936 60744938 60744939 60744943 60744946 60744949 60744951 60744952 60744954 60744963 60744965 60744966 60744967 60744968 60744973 60744977 60744982 60744983 60744984 60744986 60744987 60744989 60744990 60744991 60744993 60744995 60744997 60744998 60744999 60745000 60745747 60745749 60745751 60745755 60745758 60745765 60745774 60745787 60745791 60745796 60745798 60745807 60745809 60745856 60745857 60745859 60745860 60745861 60745862 60745864 60745865 60745866 60745867 60745872 60745874 60746815 60746821 60746826 60746835 60746839 60746840 60746844 60746850 60746856 60746859 60746862 60746864 60746865 60746877 60746879 60746880 60746882 60746883 60747037 60747044 60747046 60747048 60747059 60747060 60747063 60747072 60747073 60747081 60747097 60747101 60747105 60747109 60747110 60747399 60747407 60747415 60747417 60747418…
FDA’s list runs to 10,597 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 10,597 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.