Quadra Assura MP, Sterile EO
Medical device recall Z-2325-2018. Published in FDA’s Enforcement Report on Jul 4, 2018.
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 Jul 4, 2018. 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
- 68117 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?
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
68117, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial #: 1017247 1017246 1017239 1017238 1017248 1017242 1017243 1017245 1017240 1065733 1065741 1065742 1062125 1062118 1062120 1065717 1081661 1075944 1075939 1081656 1065721 1081665 1065724 1065734 1110961 1110163 1065740 1062122…
Every code shown here, 1,994 characters
Serial #: 1017247 1017246 1017239 1017238 1017248 1017242 1017243 1017245 1017240 1065733 1065741 1065742 1062125 1062118 1062120 1065717 1081661 1075944 1075939 1081656 1065721 1081665 1065724 1065734 1110961 1110163 1065740 1062122 1104243 1106558 1104245 1104238 1062128 1081658 1062119 1106557 1106559 1106560 1109554 1110161 1106561 1109553 1106563 1065731 1106564 1062127 1113653 1110153 1110142 1075936 1110970 1106556 1110146 1110957 1110128 1110947 1113663 1110954 1065736 1065738 1062126 1063635 1062153 1084907 1069184 1063622 1069786 1063145 1063152 1063475 1063634 1063129 1063604 1063612 1063160 1063163 1063148 1062164 1063640 1063648 1063157 1063618 1063461 1063643 1062174 1062159 1063617 1062141 1063613 1069167 1063621 1063629 1062133 1062152 1062157 1063631 1062167 1063632 1076754 1069172 1062134 1063649 1062149 1062132 1063650 1076736 1063642 1069176 1063609 1062171 1069805 1076755 1076766 1063601 1076753 1076735 1076762 1063606 1076740 1076739 1063473 1069799 1076764 1081673 1080466 1063158 1069187 1081676 1063147 1063457 1063467 1076767 1069784 1063630 1063137 1069801 1070772 1085768 1063474 1069793 1076751 1084903 1069791 1081671 1070774 1080467 1080468 1063645 1069191 1069182 1076746 1081675 1076747 1069777 1070780 1076769 1069792 1070783 1081682 1076759 1076763 1069789 1076750 1076742 1076760 1063146 1062170 1081685 1070777 1076745 1063611 1070782 1076761 1069175 1069189 1069782 1070773 1069788 1090725 1090706 1090704 1085774 1085771 1091481 1090029 1091433 1084904 1090719 1084908 1090024 1084905 1092532 1085754 1085759 1084901 1091432 1090025 1090027 1084906 1081668 1081672 1085766 1085757 1090722 1076748 1090708 1090723 1085762 1090710 1085763 1091426 1085775 1076743 1085776 1062156 1076741 1063153 1063142 1069785 1062169 1062135 1063463 1069194 1062166 1062139 1062131 1063462 1062158 1063470 1063637 1062155 1063628 1057801 1062130 1063149 1062146 1069796 1069193 1063646 1063136 1063602 1069795 1063468 1063156 1069806 1091434 1092531 1096812…
FDA’s list runs to 609,458 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.
U.S. 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 Apr 16, 2018.
- FDA classified it on Jun 28, 2018.
- FDA’s Enforcement Report published it on Jul 4, 2018.
- FDA terminated it on Mar 8, 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 609,458 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.