Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224,…
Medical device recall Z-0029-2018. 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
- 102684 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?
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
102684 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 7622391 7640623 7638962 7728212 7637541 7693570 7737307 7757416 7637955 7804389 7818448 7818627 2928935 3015767 7766148 7604248 7752195 7757623 2845326 2884548 2884290 7765809 7752168 7804384 7675903 7651148 7649402 7511167…
Every code shown here, 2,000 characters
Serial Numbers: 7622391 7640623 7638962 7728212 7637541 7693570 7737307 7757416 7637955 7804389 7818448 7818627 2928935 3015767 7766148 7604248 7752195 7757623 2845326 2884548 2884290 7765809 7752168 7804384 7675903 7651148 7649402 7511167 7729110 7729097 7639579 2948679 7595363 3002963 7817838 7617597 7650646 7650613 7603335 7694205 2992360 7641322 7636912 7618229 7649382 7649730 7638932 7906629 7650072 7652482 7641324 7641320 7640641 7639577 7638804 7728974 7638929 7638910 7843251 7906501 7817960 7727630 7649374 7650098 7637940 7637400 7637942 7636935 7637376 7636926 7640666 7640648 7727646 7739291 7784767 7727650 7784465 7906198 7906196 7833573 7783933 7817827 7784764 7784456 7847704 7842782 7842694 7784374 7784480 7511329 7784759 7843731 7906186 7728174 7731667 7731878 7783915 7844299 7904089 7842577 7727648 7843149 7842573 7784792 7784468 7784483 7845116 7842742 7683871 7641343 7641327 7641341 7640048 7701938 7906621 7637597 7628520 7723706 7728171 7649720 7709817 7693145 7649379 7637379 7599066 7728980 7629737 7681091 7728138 7617584 7582696 7628497 7599075 7638795 7607127 7640609 7615724 7629995 7641339 7709784 7590556 3138516 7681214 7640000 7898794 7834350 7844053 7844077 7575692 7844064 7574602 3138527 7847621 3138525 7893570 7904097 7906194 7844056 7549345 2856883 7728207 7693671 7709028 7729099 2988196 7639997 7549697 7701839 2988382 2989364 3010991 7549358 7549354 7575857 7549342 7601251 7608336 7599277 7604240 7590567 7599065 2954300 7615493 2943910 7601250 7594240 7594217 7605825 7622319 7622263 7615717 2988825 7784773 2947935 2947983 2955093 2954264 2988685 2940873 2991675 7524265 2948516 7527817 7527840 7524236 2945936 2856874 3002872 7775120 7617591 7742650 7739644 7739289 7766151 7749739 7899206 7739273 7845426 7739287 7739638 7742648 7742662 7742679 7766113 7765796 7893313 2954268 7906620 7843745 7895900 7895904 3140109 7898917 7895894 7536945 7904074 7904078 7904083 7899208 7899201 7898926 7847627 2829459 7574793 2856932 2846904 2845289 2801620…
FDA’s list runs to 920,586 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 920,586 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.