BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide…
Medical device recall Z-1448-2021. 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
- 490 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,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
490 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 60717860 60722974 60725417 60725753 60726857 60726883 60726910 60727193 60727205 60727215 60727225 60727234 60727253 60727408 60727417 60728042 60728047 60728050 60728804 60728809 60728810 60728811 60728813 60728825 60728852…
Every code shown here, 1,994 characters
Serial Number 60717860 60722974 60725417 60725753 60726857 60726883 60726910 60727193 60727205 60727215 60727225 60727234 60727253 60727408 60727417 60728042 60728047 60728050 60728804 60728809 60728810 60728811 60728813 60728825 60728852 60728854 60728857 60728865 60728888 60728913 60728915 60728936 60728989 60728998 60729019 60729022 60729047 60729049 60729051 60729056 60729065 60729068 60729084 60729087 60729120 60729122 60729804 60730307 60730321 60730325 60730333 60730337 60730356 60730599 60730623 60731392 60731401 60731422 60738027 60738986 60740536 60740540 60740542 60740568 60740569 60740599 60740965 60740982 60740988 60741013 60741028 60741031 60741276 60741295 60741307 60741310 60741338 60741623 60741633 60741653 60741734 60741752 60741761 60741781 60741797 60741799 60744245 60744246 60744251 60744252 60744255 60744256 60744258 60744259 60744261 60744285 60744286 60744288 60744289 60744292 60744295 60744296 60744299 60744304 60744307 60744311 60744312 60744313 60744314 60744316 60744321 60744918 60744919 60744921 60744924 60744926 60744930 60744933 60744934 60744937 60744940 60744948 60744953 60744957 60744958 60744959 60744960 60744961 60744964 60744970 60744972 60744974 60744976 60744978 60744979 60744981 60744985 60744988 60744992 60745002 60745003 60745746 60745752 60745753 60745754 60745756 60745757 60745760 60745761 60745763 60745767 60745768 60745769 60745771 60745772 60745773 60745775 60745776 60745778 60745781 60745788 60745790 60745793 60745797 60745799 60745800 60745804 60745810 60745811 60745813 60745814 60745855 60745858 60745868 60745869 60745871 60746822 60746824 60746825 60746827 60746829 60746830 60746831 60746832 60746834 60746836 60746841 60746843 60746845 60746846 60746847 60746848 60746851 60746852 60746854 60746858 60746860 60746863 60746876 60746878 60746881 60747043 60747047 60747049 60747056 60747058 60747075 60747083 60747084 60747085 60747086 60747089 60747092 60747406 60747412 60747429 60747430 60747431 60747432 60747435…
FDA’s list runs to 4,414 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 4,414 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.