Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210,…
Medical device recall Z-0030-2018. 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
- 529912 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?
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 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
529912 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 2759491 2712645 2721539 2780831 2712625 2717492 2717871 2736600 2717397 2714912 2768520 2721733 2721752 2712653 2762819 2736601 2736644 2780837 2780832 2717477 2740357 2740399 2717872 2717878 2714878 2736611 2736639 2736649…
Every code shown here, 2,000 characters
Serial Numbers: 2759491 2712645 2721539 2780831 2712625 2717492 2717871 2736600 2717397 2714912 2768520 2721733 2721752 2712653 2762819 2736601 2736644 2780837 2780832 2717477 2740357 2740399 2717872 2717878 2714878 2736611 2736639 2736649 2717400 2721570 2740394 2717500 2805600 2712642 2840094 2859254 2799954 2799945 3067828 2805829 2953350 2805840 2859262 2808720 2862603 2790810 2820148 2862599 2953185 2953376 2721748 2762847 2762833 2762836 2872389 2953390 2749844 2953394 2953349 2953182 2953366 2953329 2955340 2773029 2728721 2721768 2799983 2762812 2774498 2774483 2832212 2762754 2721573 2780829 2780824 2780805 2780785 2740375 2768559 2762861 2855201 2762781 2762807 2780770 2762856 2736630 2794367 2832272 2871419 2833615 2862614 2872529 2805612 2855206 2794638 2721749 2780792 2832963 2832989 2855217 2790826 2717515 2762759 2773014 2855202 2727395 2727382 2736646 2762850 2773030 2874302 2721753 2788556 2780339 2832257 2790835 2808759 2788742 2788727 2855223 2788706 2855216 2845835 2805627 2805826 2868281 2788539 2871416 2799972 2913205 2874280 2916937 2916955 2913246 2913247 2913224 2913216 2874282 2913208 2913227 2913226 2913255 2913236 2889787 2913232 2928134 2788721 2916947 2916922 2916960 2916965 2916924 2916964 2773081 2913251 2928871 2871413 2872543 2872387 2871415 2917179 2476768 2524636 2520762 2524628 2523935 2520769 2889848 2476736 2524674 2476162 2459127 2458690 2443485 2759489 2759517 2520784 2574279 2874304 2774517 2635736 2574178 2574157 2572326 2524641 2574284 2524673 2574275 2574185 2574168 2366053 2524700 2773037 2572313 2855232 2855632 2872367 2805625 2820119 2820134 2849300 2833622 2859242 2855620 2862593 2862616 2865667 2865707 2870389 2833614 2872384 2865661 2859236 2802267 2865696 2820124 2820138 2796327 2872552 2805885 2840076 2855572 2871414 2872364 2874307 2819450 2874294 2872392 2872372 2872548 2872553 2874277 2872532 2874288 2872366 2874341 2874338 2874285 2874286 2874283 2874301 2872380 2872535 2788735 2872557 2855580 2872542 2872539…
FDA’s list runs to 4,765,771 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 4,765,771 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.