EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System
Medical device recall Z-0935-2021. Published in FDA’s Enforcement Report on Feb 3, 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 Feb 3, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 7093 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?
Accelerated battery depletion may result in a need for device replacement earlier than expected.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
7093 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers distributed in the US: 101624 101701 101757 101808 101835 101845 101869 101878 101946 101953 101957 101958 101960 102009 102048 102055 102060 102061 102074 102079 102081 102096 102120 102129 102177 102178 102183 102190…
Every code shown here, 1,998 characters
Serial numbers distributed in the US: 101624 101701 101757 101808 101835 101845 101869 101878 101946 101953 101957 101958 101960 102009 102048 102055 102060 102061 102074 102079 102081 102096 102120 102129 102177 102178 102183 102190 102194 102195 102196 102205 102220 102239 102251 102272 102277 102307 102319 102334 102383 102384 102403 102406 102409 102416 102418 102426 102428 102432 102438 102441 102452 102473 102491 102495 102505 102522 102535 102536 102540 102543 102546 102550 102557 102558 102561 102564 102565 102568 102571 102573 102574 102575 102576 102577 102578 102581 102583 102585 102586 102587 102589 102590 102593 102594 102595 102596 102597 102598 102599 102602 102603 102609 102615 102616 102617 102618 102620 102622 102625 102626 102627 102628 102630 102638 102641 102642 102645 102647 102648 102650 102651 102652 102655 102657 102658 102660 102661 102662 102664 102666 102667 102668 102670 102673 102674 102675 102677 102678 102679 102680 102683 102684 102685 102686 102687 102688 102689 102690 102691 102692 102693 102694 102695 102696 102697 102698 102699 102701 102702 102703 102705 102707 102709 102713 102714 102717 102721 102723 102724 102725 102726 102727 102728 102730 102731 102732 102734 102735 102736 102737 102738 102739 102740 102741 102742 102745 102746 102748 102749 102750 102754 102755 102756 102757 102758 102759 102762 102763 102764 102765 102766 102767 102771 102772 102773 102774 102777 102778 102779 102780 102782 102783 102786 102787 102788 102790 102793 102794 102796 102797 102802 102806 102810 102812 102813 102814 102815 102816 102818 102819 102820 102821 102825 102826 102827 102829 102830 102831 102832 102833 102834 102835 102837 102838 102840 102845 102846 102847 102851 102853 102854 102858 102859 102860 102861 102864 102865 102866 102867 102868 102869 102870 102871 102873 102874 102875 102876 102877 102878 102879 102880 102882 102883 102884 102885 102886 102889 102890 102892 102893 102894 102895 102897 102898 102901 102903 102904 102905…
FDA’s list runs to 128,060 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
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Dec 2, 2020.
- FDA classified it on Jan 28, 2021.
- FDA’s Enforcement Report published it on Feb 3, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Boston Scientific Corporation, of Saint Paul, MN.
- 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 128,060 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.