BIOTRONIK IPERIA 7, DR-T DF4 ProMRI
Medical device recall Z-1453-2021. 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
- 2881 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 DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
2881 UNITS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60826231 60826274 60826822 60834578 60834590 60834592 60834595 60834602 60834610 60834618 60834627 60834628 60834640 60835705 60835712 60836005 60836015 60836158 60836479 60836767 60836769 60836770 60836771 60836775 60836776…
Every code shown here, 1,994 characters
Serial Number 60826231 60826274 60826822 60834578 60834590 60834592 60834595 60834602 60834610 60834618 60834627 60834628 60834640 60835705 60835712 60836005 60836015 60836158 60836479 60836767 60836769 60836770 60836771 60836775 60836776 60836777 60836779 60836782 60836787 60836788 60836802 60836809 60836812 60836824 60836830 60836935 60836941 60836944 60836963 60836979 60836985 60837879 60837889 60837892 60837919 60837922 60837924 60837928 60837932 60838019 60838020 60838056 60838060 60838064 60838082 60838095 60838106 60838107 60838110 60838382 60838656 60838668 60838670 60838673 60838674 60838680 60838683 60838689 60838704 60838941 60839108 60839144 60839263 60839808 60839811 60839827 60839830 60839833 60839838 60839841 60839845 60839857 60839863 60839868 60839871 60839873 60839874 60839875 60840403 60840404 60840406 60840411 60840414 60840420 60840421 60840422 60840444 60840454 60840459 60840460 60840638 60841087 60841090 60841146 60841153 60841154 60841156 60841157 60841159 60841160 60841165 60841166 60841167 60841170 60841179 60841186 60841193 60841195 60841196 60841202 60841206 60841208 60841210 60841215 60841220 60841226 60841230 60841235 60841238 60841241 60841365 60841370 60841505 60841509 60841512 60841968 60841974 60842003 60842004 60843951 60843978 60843984 60843986 60843987 60843988 60843999 60844007 60844016 60844018 60844342 60844344 60844345 60844346 60844349 60844355 60844357 60844360 60844361 60844368 60844370 60844374 60844375 60844382 60844386 60844388 60844389 60844397 60844400 60844421 60844430 60844699 60844700 60844701 60844705 60844727 60844728 60844730 60844732 60844738 60844740 60844741 60844742 60844743 60844744 60844745 60845578 60845585 60845586 60845593 60845597 60845599 60845601 60845602 60845603 60845605 60845606 60846068 60846070 60846072 60846075 60846078 60846083 60846085 60846086 60846088 60846089 60846090 60846100 60846105 60846130 60846310 60846871 60846872 60846873 60846880 60846881 60846955 60846956 60846972 60846980…
FDA’s list runs to 25,942 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 25,942 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.