Quadra Assura
Medical device recall Z-0117-2017. Published in FDA’s Enforcement Report on Nov 2, 2016.
- 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 Nov 2, 2016. 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
- 193,954 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?
St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided 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. 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
193,954 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
651567 651568 651569 651571 651572 651573 651574 651575 652141 652143 652144 652145 652147 652148 652150 652311 652312 652313 652314 652315 652316 652317 652318 652319 652320 1006608 1006609 1006610 1006611 1006612 1006613 1006614 1006615…
Every code shown here, 1,999 characters
651567 651568 651569 651571 651572 651573 651574 651575 652141 652143 652144 652145 652147 652148 652150 652311 652312 652313 652314 652315 652316 652317 652318 652319 652320 1006608 1006609 1006610 1006611 1006612 1006613 1006614 1006615 1006616 1006617 1006618 1006619 1006620 1006621 1006622 1006623 1006624 1006625 1006626 1006627 1006628 1006629 1006630 1006631 1006633 1006634 1006635 1006636 1006637 1006638 1006639 1006640 1006641 1006642 1006643 1006644 1017620 1017621 1017622 1017623 1017624 1017625 1017626 1017628 1017629 1017630 1017631 1017632 1017633 1017634 1017635 1017636 1017637 1017638 1017639 1017640 1017641 1017642 1017643 1017644 1017645 1017646 1017647 1017648 1017649 1017651 1017652 1017654 1017655 1017656 1017657 1017658 1017659 1017660 1017661 1017662 1017663 1017664 1017665 1017666 1017667 1028491 1028492 1028493 1033490 1033491 1033492 1033493 1033494 1033495 1033496 1033497 1033498 1033499 1033500 1050686 1050688 1050689 1050691 1050692 1050694 1050695 1050696 1050697 1057850 1057851 1057852 1057853 1057854 1057855 1057858 1057859 1057860 1057862 1057863 1057864 1057865 1057867 1057868 1057869 1057870 1057872 1057873 1057874 1059067 1059068 1059069 1059070 1059071 1059072 1059073 1059074 1059075 1059076 1059077 1059078 1059079 1059080 1059081 1059082 1059084 1059085 1059086 1059087 1059088 1059089 1059090 1059091 1059092 1059093 1059094 1059095 1059096 1099092 1099093 1099094 1099095 1099097 1099098 1099099 1099100 1099101 1099102 1099103 1099104 1099105 1099106 1099107 1099108 1099109 1099110 1099111 1099112 1099113 1099415 1099416 1099417 1099418 1099419 1099420 1099421 1099422 1099423 1099424 1099425 1099426 1099427 1099428 1099429 1099430 1099431 1099432 1099433 1099434 1099435 1099436 1099437 1099438 1099440 1099441 1099442 1099443 1099444 7000000 7000002 7000003 7000005 7000006 7000007 7000008 7000009 7000121 7000122 7000123 7000124 7000125 7000126 7000127 7000128 7000129 7000240 7000241 7000242 7000243 7000244 7000245 7000246 7000247…
FDA’s list runs to 888,245 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.
Worldwide Distribution - US (nationwide) and OUS
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 Oct 10, 2016.
- FDA classified it on Oct 21, 2016.
- FDA’s Enforcement Report published it on Nov 2, 2016.
- FDA terminated it on Sep 27, 2018.
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 888,245 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.