ASSURITY Pulse Generator
Medical device recall Z-1530-2021. Published in FDA’s Enforcement Report on May 19, 2021.
- FDA Class I
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 May 19, 2021. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 50 states named
- 242,945 pacemakers [updated 3/20/2023] 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
242,945 pacemakers [updated 3/20/2023], in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Assurity Pacemaker Model Number/UDI (GTIN): PM1240 / 05414734507066 PM2240 / 05414734507073 PM2260 / 05414734507097 PM1272 / 05414734509572 PM2272 / 05414734509589 Serial Numbers: 7628828 7629513 7629762 7630106 7630232 7630233 7630235…
Every code shown here, 1,996 characters
Assurity Pacemaker Model Number/UDI (GTIN): PM1240 / 05414734507066 PM2240 / 05414734507073 PM2260 / 05414734507097 PM1272 / 05414734509572 PM2272 / 05414734509589 Serial Numbers: 7628828 7629513 7629762 7630106 7630232 7630233 7630235 7630364 7630367 7630369 7630370 7630371 7630372 7630383 7630394 7630397 7630398 7630399 7630400 7630401 7630402 7630403 7630413 7630421 7630428 7630429 7630430 7630431 7630432 7630435 7630442 7630443 7630724 7630725 7630726 7630727 7630729 7630730 7630731 7630732 7630733 7630734 7630736 7630737 7630738 7630739 7630740 7630741 7630742 7630743 7630744 7630745 7630746 7630747 7630748 7630749 7630750 7630751 7630752 7630753 7630754 7630755 7630756 7630757 7630758 7630759 7630760 7630763 7630764 7630765 7630766 7630767 7630768 7630769 7630771 7630772 7630773 7630774 7630776 7630777 7630778 7630779 7630780 7630781 7630782 7630783 7630784 7630785 7630786 7630787 7630788 7630789 7630791 7630792 7630793 7630794 7630795 7630796 7630797 7630798 7630799 7630800 7630801 7630802 7630803 7630804 7630805 7630806 7630807 7630808 7630810 7630811 7630812 7630813 7630814 7630815 7630816 7630817 7630819 7630820 7630821 7630822 7630823 7630824 7630825 7630828 7630829 7630831 7630832 7630833 7630854 7630856 7630858 7630859 7630860 7630862 7630863 7630864 7630865 7630866 7630867 7630868 7630869 7630870 7630871 7630872 7630873 7630874 7630875 7630876 7630877 7630878 7630879 7630880 7630881 7630882 7630883 7630884 7630885 7630886 7630887 7630888 7630889 7630890 7630891 7630892 7630893 7630894 7630896 7630897 7630899 7630901 7630902 7630903 7630904 7630905 7630906 7630907 7630908 7630909 7630910 7630911 7630913 7630914 7630915 7630916 7630917 7630918 7630919 7630921 7630922 7630923 7630924 7630925 7630926 7630927 7630928 7630929 7630930 7630931 7630932 7630933 7630934 7630935 7630937 7630938 7630939 7630940 7630941 7630943 7630944 7630945 7630946 7630947 7630948 7630949 7630950 7630951 7630952 7630953 7631224 7631225 7631226 7631227 7631228 7631230 7631231…
FDA’s list runs to 1,952,331 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: U.S (nationwide) to states including.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.( countries): [806 Amendment - after March 2021 - updated 3/20/2023] Algeria, Angola, Argentina, Aruba, Australia, Austria, Bahrain, Bangladesh, Belgium, Benin, Bolivia, Brazil, Bulgaria, Cameroon, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Ireland, Italy, Japan, Jordan, Korea, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico, Montenegro, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Palestine, Panama, Paraguay, Peru Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Senegal, Servia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen.
The states and territories these words name
50 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Mar 15, 2021.
- FDA classified it on May 7, 2021.
- FDA’s Enforcement Report published it on May 19, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- St. Jude Medical, Cardian Rhythm Management Division, 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 1,952,331 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.