Assurity MRI
Medical device recall Z-0031-2018. 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
- 164366 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 MRI Model Numbers: PM1272, PM2272 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
164366 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 4614099 4596216 4596638 4727863 4611510 4614078 4611861 4611876 4635855 4616825 4728102 4619514 4611919 4621031 4621034 4620372 4620495 4618816 4778046 4647279 4739147 4652154 4611355 4611962 4781006 4782745 4762369 4580750…
Every code shown here, 2,000 characters
Serial Numbers: 4614099 4596216 4596638 4727863 4611510 4614078 4611861 4611876 4635855 4616825 4728102 4619514 4611919 4621031 4621034 4620372 4620495 4618816 4778046 4647279 4739147 4652154 4611355 4611962 4781006 4782745 4762369 4580750 4580699 4727919 4737221 4727846 4740088 4740697 4736769 4740335 4727012 4727917 4738401 4641014 4580684 4617156 4621413 4648598 4647009 4662138 4621077 4652686 4652526 4645582 4621012 4617402 4647544 4611377 4617938 4782292 4782687 4762387 4782229 4737273 4647864 4726629 4634656 4629019 4740653 4726989 4739143 4601150 4727010 4727803 4614087 4596511 4650941 4740363 4737514 4580630 4580765 4739963 4580806 4738879 4647284 4728018 4639005 4635760 4644659 4629592 4665627 4679417 4641180 4638907 4617405 4639221 4600690 4638206 4670070 4639034 4646675 4624054 4624121 4650482 4646990 4639228 4601060 4610758 4611562 4782767 4782661 4765479 4765426 4586367 4596542 4629057 4586901 4596565 4600219 4600082 4600064 4600706 4588272 4587514 4580702 4619222 4596547 4611578 4620386 4639247 4645279 4665777 4634659 4629018 4645618 4633643 4640711 4620991 4634198 4611532 4620473 4621466 4653223 4609915 4611591 4611560 4667233 4639385 4586354 4618620 4611592 4782618 4764889 4778026 4587483 4588274 4588271 4627257 4586356 4652960 4586371 4726854 4739977 4740047 4580742 4586915 4601236 4639394 4586365 4727890 4727805 4580718 4724051 4724200 4580580 4580789 4596541 4646734 4737883 4603213 4738113 4601936 4602110 4741253 4728277 4738875 4737458 4762401 4737885 4652993 4652211 4649311 4653031 4652983 4614968 4652179 4652204 4652722 4601219 4652501 4580695 4652536 4652680 4650491 4663590 4662182 4663023 4728270 4653260 4652212 4642810 4630327 4665015 4670157 4638685 4641158 4639203 4635313 4782809 4640041 4647802 4639380 4639461 4639035 4640130 4667315 4638719 4633352 4673479 4665315 4611362 4663513 4663619 4622350 4617363 4652694 4618004 4618795 4647285 4636531 4622592 4634171 4653033 4661840 4650863 4652958 4662821 4651547 4652178 4619787 4617933 4650458…
FDA’s list runs to 1,475,737 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 1,475,737 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
-
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.