BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI
Medical device recall Z-1449-2021. 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
- 3,832 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,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
3,832 UNITS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60824541 60825066 60828115 60829523 60829525 60829530 60829531 60829534 60829535 60829536 60829537 60829538 60829539 60829562 60829569 60831618 60831793 60831798 60831799 60831801 60831802 60831805 60831871 60831886 60831887…
Every code shown here, 1,994 characters
Serial Number 60824541 60825066 60828115 60829523 60829525 60829530 60829531 60829534 60829535 60829536 60829537 60829538 60829539 60829562 60829569 60831618 60831793 60831798 60831799 60831801 60831802 60831805 60831871 60831886 60831887 60831893 60831918 60831924 60831925 60832194 60833094 60833105 60833106 60833107 60833110 60833112 60833113 60833116 60833119 60833120 60833122 60833130 60833136 60833138 60833146 60833148 60833677 60833687 60833692 60833700 60833701 60833703 60833707 60833708 60833724 60834092 60834093 60834095 60834098 60834103 60834108 60834109 60834112 60834115 60834116 60834117 60834121 60834134 60834147 60834149 60834151 60834156 60834159 60834167 60834190 60834193 60834195 60834198 60834199 60834234 60834238 60834240 60834241 60834245 60834248 60834260 60834457 60834459 60834462 60834464 60834470 60834476 60834478 60834479 60834480 60834490 60834491 60834495 60834500 60834506 60834511 60834514 60834523 60834527 60834534 60834820 60834821 60834826 60834832 60834838 60834840 60834842 60834851 60834855 60834856 60834866 60834878 60834883 60834885 60835649 60835654 60835660 60835669 60835971 60835979 60835997 60836200 60836202 60836233 60836235 60836238 60837161 60837170 60837190 60837192 60837205 60837210 60837217 60837221 60837225 60837228 60837351 60837365 60837379 60837382 60837386 60837399 60837400 60837403 60837413 60837415 60837421 60837423 60837825 60837826 60837831 60837834 60837838 60837840 60837843 60837844 60837851 60837852 60838203 60838209 60838213 60838215 60838216 60838217 60838220 60838225 60838226 60838227 60838237 60838238 60838242 60838243 60838244 60838246 60838247 60838250 60838252 60838254 60838255 60838260 60838265 60838269 60838270 60838271 60838453 60838459 60838462 60838465 60838475 60838480 60838482 60838489 60838498 60838503 60838505 60838507 60838508 60838510 60838515 60838516 60838518 60838522 60838751 60838759 60838763 60838769 60838771 60838774 60838775 60838776 60838843 60838854 60838857 60838858 60838862…
FDA’s list runs to 34,502 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 34,502 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.