EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System
Medical device recall Z-0936-2021. 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
- 11296 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 MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
11296 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 United States: 100371 100467 100485 100548 100591 100641 100705 100710 100717 100742 100745 100791 100866 100868 200019 200023 200031 200043 200049 200067 200125 200126 200127 200128 200129 200152 200157…
Every code shown here, 1,995 characters
Serial numbers distributed in the United States: 100371 100467 100485 100548 100591 100641 100705 100710 100717 100742 100745 100791 100866 100868 200019 200023 200031 200043 200049 200067 200125 200126 200127 200128 200129 200152 200157 200161 200163 200167 200170 200171 200176 200181 200182 200185 200186 200187 200190 200191 200192 200195 200198 200214 200217 200224 200228 200232 200236 200239 200241 200244 200247 200251 200256 200258 200261 200262 200264 200266 200269 200276 200283 200287 200290 200291 200293 200297 200300 200301 200313 200317 200330 200331 200333 200335 200341 200347 200348 200351 200358 200359 200360 200366 200367 200368 200369 200370 200372 200373 200374 200375 200378 200381 200382 200384 200386 200388 200389 200390 200391 200394 200398 200402 200403 200406 200410 200422 200423 200425 200426 200428 200431 200435 200436 200437 200441 200442 200444 200445 200448 200449 200452 200453 200461 200465 200468 200469 200470 200471 200473 200479 200481 200482 200488 200491 200493 200497 200503 200506 200510 200511 200515 200517 200518 200519 200524 200527 200533 200535 200536 200543 200545 200546 200553 200554 200555 200556 200557 200563 200564 200567 200574 200575 200577 200579 200580 200584 200585 200587 200588 200589 200590 200591 200592 200593 200595 200598 200599 200600 200604 200605 200606 200607 200620 200624 200625 200628 200629 200631 200634 200636 200637 200641 200642 200645 200648 200651 200654 200656 200657 200658 200659 200663 200665 200667 200669 200671 200677 200679 200680 200683 200684 200685 200688 200689 200691 200692 200693 200696 200698 200702 200703 200704 200705 200707 200712 200713 200716 200717 200718 200719 200721 200723 200726 200727 200729 200730 200738 200739 200740 200741 200742 200743 200745 200746 200747 200748 200749 200750 200752 200753 200754 200755 200760 200761 200762 200763 200770 200775 200777 200778 200779 200782 200783 200786 200787 200794 200800 200801 200802 200803 200805 200806 200810 200811 200812 200814…
FDA’s list runs to 168,901 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 168,901 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.