BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4
Medical device recall Z-1454-2021. 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
- 702 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 INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
702 UNITS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60841286 60869296 60870124 60870125 60870127 60870130 60870131 60870132 60870136 60870140 60870141 60870142 60870143 60873307 60873308 60873309 60873310 60873311 60873314 60873315 60873316 60873317 60873319 60873320 60873321…
Every code shown here, 1,994 characters
Serial Number 60841286 60869296 60870124 60870125 60870127 60870130 60870131 60870132 60870136 60870140 60870141 60870142 60870143 60873307 60873308 60873309 60873310 60873311 60873314 60873315 60873316 60873317 60873319 60873320 60873321 60873322 60873323 60873324 60873325 60873326 60875170 60875171 60875172 60875173 60875174 60875175 60875176 60875177 60875178 60875179 60878810 60878815 60878816 60878817 60878818 60878819 60878821 60878822 60878823 60878824 60878825 60878826 60878828 60878829 60878830 60878831 60878832 60878833 60878834 60878837 60878838 60880125 60880127 60880128 60880129 60880130 60880131 60880133 60880134 60880135 60880144 60880147 60880148 60880149 60881382 60881383 60881386 60881387 60881388 60881389 60881390 60881393 60881394 60881397 60881398 60881399 60881401 60881403 60881404 60881405 60881619 60881620 60881621 60881622 60881624 60881625 60881627 60881628 60881631 60881633 60881634 60881636 60881639 60881643 60881644 60881646 60883307 60883308 60883310 60883311 60883314 60883315 60883316 60883317 60883318 60883319 60883320 60883322 60883323 60883324 60883325 60883326 60884278 60884279 60884280 60884281 60884283 60884284 60884285 60884286 60884287 60884288 60884289 60884290 60884291 60884293 60884294 60884295 60884296 60884991 60884993 60884994 60884997 60884998 60884999 60885003 60885004 60885006 60885007 60885008 60885009 60885010 60886020 60886022 60886023 60886024 60886025 60886026 60886028 60886381 60886382 60886384 60886385 60886387 60886389 60886390 60886561 60886562 60886563 60886564 60886566 60886567 60886568 60886569 60886570 60886571 60886572 60886573 60886574 60886576 60886577 60886578 60886579 60886580 60886581 60886584 60886587 60886588 60886589 60886590 60888201 60888202 60888203 60888204 60888206 60888207 60888208 60888209 60888211 60888212 60888213 60888214 60888217 60888218 60888219 60889372 60889373 60889376 60889377 60889380 60889381 60889382 60889384 60889385 60889386 60889390 60889391 60889392 60889393 60889394…
FDA’s list runs to 6,331 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 6,331 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.