PM1214 NUANCE SR RF
Medical device recall Z-0034-2018. Published in FDA’s Enforcement Report on Oct 25, 2017.
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 25, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 2741 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?
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart’s intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
2741 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 2678856 2678867 2678859 2678857 2678877 2678872 2678870 2678869 2683929 2678863 2678858 2678866 2678878 2678868 2678860 2678874 2678879 2678864 2683921 2673458 2683918 2683917 2683914 2683928 2683927 2678862 2683922 2678880…
Every code shown here, 2,000 characters
Serial Numbers: 2678856 2678867 2678859 2678857 2678877 2678872 2678870 2678869 2683929 2678863 2678858 2678866 2678878 2678868 2678860 2678874 2678879 2678864 2683921 2673458 2683918 2683917 2683914 2683928 2683927 2678862 2683922 2678880 2683920 2683930 2683911 2683916 2675733 2678861 2678871 2683923 2673452 2678876 2675748 2675747 2675742 2675737 2675731 2675743 2673467 2675739 2673449 2673448 2673457 2673459 2673469 2673468 2673466 2673465 2675727 2683924 2678865 2675734 2675728 2675725 2675736 2675745 2675740 2678875 2675732 2675730 2675749 2675746 2675738 2675729 2675735 2675726 2692492 2689903 2691326 2691327 2691328 2691334 2691330 2683919 2689905 2691332 2692495 2692497 2692483 2692488 2692489 2692490 2691329 2689901 2678873 2689899 2689908 2689906 2689907 2689897 2691325 2689900 2691333 2689898 2689909 2689904 2689902 2689896 2691331 2692481 2689910 2686717 2692491 2686730 2686728 2686722 2686721 2686726 2686712 2686718 2686723 2686720 2686715 2683913 2683915 2683926 2683912 2683925 2686725 2692485 2675741 2692482 2692499 2692500 2692493 2692494 2686714 2692484 2692487 2686729 2686719 2686716 2686711 2686713 2686727 2686724 2692496 2697416 2697406 2697407 2697411 2697415 2697401 2697403 2697408 2697405 2697413 2697414 2697412 2697409 2697410 2697419 2697400 2613924 2697404 2613921 2613928 2617417 2613927 2613937 2613925 2613943 2697417 2613926 2699066 2613920 2613919 2673464 2613917 2675744 2692486 2692498 2613923 2699063 2697402 2700386 2700385 2699072 2700388 2699069 2700394 2699065 2700389 2699060 2699059 2699058 2699055 2697418 2699057 2699061 2699073 2700382 2699062 2699056 2699067 2699071 2699068 2699074 2700392 2699070 2613918 2700384 2700387 2700393 2700390 2700381 2700380 2700383 2699064 2646730 2613916 2646718 2613930 2646736 2646735 2646734 2645827 2646731 2646728 2646727 2646726 2646725 2646723 2646722 2646721 2646732 2673454 2673463 2673462 2673461 2673460 2673456 2673447 2646719 2673455 2646733 2673453 2673451 2673450 2673445 2646724 2646729…
FDA’s list runs to 21,943 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
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?
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 19, 2017.
- FDA’s Enforcement Report published it on Oct 25, 2017.
- FDA terminated it on Jul 8, 2020.
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 21,943 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.