Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify…
Medical device recall Z-0004-2018. Published in FDA’s Enforcement Report on Oct 18, 2017.
- FDA Class I
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 Oct 18, 2017. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 89,109 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The device may exhibit premature battery depletion.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
89,109 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 591144 617036 625707 7008535 629874 641260 627997 638226 1017774 1043239 1018436 1002811 7012648 7005554 616343 593297 595815 760130 607175 633948 717548 1003642 721997 795698 747687 638422 592934 637368 745438 743874…
Every code shown here, 1,999 characters
Serial Numbers: 591144 617036 625707 7008535 629874 641260 627997 638226 1017774 1043239 1018436 1002811 7012648 7005554 616343 593297 595815 760130 607175 633948 717548 1003642 721997 795698 747687 638422 592934 637368 745438 743874 739328 805873 788997 754856 605200 593643 618895 607352 622756 622614 614876 790329 613202 613336 761682 606830 605798 607041 603157 635630 640359 746514 807431 795684 1043148 597053 628368 612783 633942 624009 601128 595811 717522 594212 1018396 1000850 1001632 752494 747710 1045252 1045256 805934 611488 629857 618366 595417 630122 633371 609158 632187 7013706 632292 7013927 7005155 648250 7021934 7008561 7005346 641258 7015283 642552 643189 1043139 810204 1001652 825628 7012674 7008095 1000251 1043273 7030287 715845 1045234 613757 7009099 7009100 7008909 715847 715555 1010487 1011017 784541 632854 721993 7012638 720848 7019523 648487 7029382 1043119 7007382 1045217 620991 727210 1043274 1045211 631035 606467 1009511 1046762 1043151 1043130 7008091 7008738 7008716 7008737 7007538 7008929 604412 602472 641652 615142 1047187 825659 7008083 609878 648253 603795 7013524 601644 7005542 746547 1003581 7008744 826111 811229 630919 1003588 728697 1114014 1017805 639881 602044 627467 606843 1043110 750041 749819 1009680 7021438 7012602 7005163 627218 7012661 7012676 749812 1010484 7021905 728735 605307 640354 7005347 1010996 1043295 1011053 1011045 639585 1045259 1043258 825663 1043247 720479 616198 638573 1000865 7021940 1043244 1047071 7029403 7005367 604493 7005369 7015745 1043269 1015750 769419 758003 1001636 7005732 7005724 7012301 639303 1017827 795184 1009528 7012595 1017809 811118 811429 784564 1018398 1009632 811589 1047152 746501 7012669 640700 7008074 7009104 7029387 7015532 7007676 7030251 7030252 7011855 7029365 7006955 1047138 1045221 1043098 1001637 7029411 7007678 7012302 1018402 1017837 633954 602386 1010520 7029385 7029390 1018437 605297 7008571 788969 761299 7020616 615275 1043131 1045210 761862 611637 761840 740810 7012613…
FDA’s list runs to 771,111 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 Distribution
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.
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 Aug 28, 2017.
- FDA classified it on Oct 10, 2017.
- FDA’s Enforcement Report published it on Oct 18, 2017.
- FDA terminated it on Jan 20, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- St Jude Medical Inc., of Sylmar, CA.
- 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 771,111 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.