PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be…
Medical device recall Z-0037-2018. 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
- 6051 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?
PM 1260 ASSURITY + 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.
6051 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 4471223 4435620 4471226 4478259 4473923 4465800 4465795 2960123 4471236 4465866 2960119 4480805 4456626 4456605 4456614 4456609 4455665 4470374 2992215 4470251 4478226 2992206 4435532 4436165 4442557 2888746 2992230 4470249…
Every code shown here, 2,000 characters
Serial Numbers: 4471223 4435620 4471226 4478259 4473923 4465800 4465795 2960123 4471236 4465866 2960119 4480805 4456626 4456605 4456614 4456609 4455665 4470374 2992215 4470251 4478226 2992206 4435532 4436165 4442557 2888746 2992230 4470249 2992219 4481080 4477111 4486603 2992337 4478246 3028382 4470221 2992336 4470256 4470255 4477145 4477154 2992244 4479101 4470215 2817358 2897784 2897779 2897791 2878499 2912102 2912129 2912137 2912163 4427305 2992294 2992270 2992271 2870627 2888748 2912140 2912167 2912110 2912100 4419728 4428451 4495360 4428446 2992205 4479087 4485695 4486629 4486616 4486619 4486415 2992291 2992304 2992208 3028378 2992262 2836144 2992265 2992233 2992331 2992298 2992316 2992225 2992322 2992338 2992221 4480798 2992275 4583284 4507998 4505995 4508010 4540176 4495349 4501470 4510860 4508966 4495359 4535417 4507981 4427067 4508009 4552833 4501456 4505305 4505336 4505325 4505323 4506025 4506017 4507994 4505996 4486592 4568194 4510873 4589129 4548069 4513308 4510893 4450734 4495355 4599671 4538400 4507977 4552843 4505329 4506013 4505297 4505998 4545146 4495352 4505307 4495365 4444189 4420503 2880064 2992334 4486626 4486643 4428621 4486590 2866157 4490599 4510886 4444178 4595435 4435633 4481085 4450718 4450724 4450716 4450730 4478258 4478225 4452570 4444187 4535401 4450688 4508013 4508988 4508971 4508983 4510007 4510031 4510878 4508960 4510011 4522001 4505987 4535413 4535405 4536286 4536287 4538398 2912136 4538415 4510012 4536284 4509990 4510987 4441673 4445638 4445615 4445647 4444191 4444206 4444169 4441652 4441667 2958460 4436172 4436157 4436241 4435240 4435220 4435258 4428465 4428473 4428463 4442581 4427298 4429259 4417850 4419718 4419726 4428439 4428461 4428459 4428619 4429264 2992263 4436159 4502697 4502681 4502703 4502700 4502692 4508961 4513296 4428447 2992279 4436184 2992284 2992223 4417858 2992295 4418150 2992227 2992202 2992285 4462727 2992305 2992247 2992255 4513550 2992333 4445644 4513541 4456618 4455658 4462697 4462677 4462679 4445614 4442609…
FDA’s list runs to 48,423 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 48,423 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.