ENDURITY Pulse Generator
Medical device recall Z-1531-2021. 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
- 95,042 pacemakers [updated 03/20/2023] 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?
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
95,042 pacemakers [updated 03/20/2023], in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Endurity Pacemaker Model Number/UDI (GTIN): PM1160 / 05414734507042 PM2160 / 05414734507059 PM1152 / 05414734509763 PM2152 / 05414734509770 PM1172 / 05414734509596 PM2172 / 05414734509602 Serial Numbers: 7649831 7650690 7650710 7650712…
Every code shown here, 1,996 characters
Endurity Pacemaker Model Number/UDI (GTIN): PM1160 / 05414734507042 PM2160 / 05414734507059 PM1152 / 05414734509763 PM2152 / 05414734509770 PM1172 / 05414734509596 PM2172 / 05414734509602 Serial Numbers: 7649831 7650690 7650710 7650712 7650713 7650715 7650718 7650727 7650742 7650800 7650801 7650802 7650806 7650809 7650811 7650815 7650816 7650817 7650818 7650820 7650821 7650822 7650823 7650824 7650826 7650969 7650971 7650974 7650975 7650976 7650978 7650979 7650980 7650982 7650983 7650984 7650985 7650986 7650987 7650988 7650989 7650990 7650992 7650993 7650994 7650995 7650997 7650998 7651000 7651001 7651002 7651004 7651005 7651006 7651008 7651010 7651011 7651012 7651014 7651015 7651016 7651017 7651018 7651019 7651020 7651021 7651023 7651024 7651027 7651028 7651169 7651171 7651172 7651173 7651174 7651175 7651176 7651177 7651179 7651180 7651181 7651182 7651183 7651185 7651186 7651187 7651188 7651189 7651190 7651191 7651192 7651193 7651194 7651196 7651197 7651198 7651199 7651200 7651201 7651202 7651204 7651205 7651206 7651207 7651208 7651211 7651213 7651214 7651215 7651216 7651218 7651220 7651221 7651222 7651223 7651225 7651226 7651228 7651339 7651340 7651341 7651342 7651344 7651345 7651347 7651348 7651349 7651350 7651351 7651352 7651354 7651355 7651356 7651357 7651359 7651360 7651361 7651362 7651364 7651366 7651367 7651368 7651369 7651370 7651371 7651372 7651373 7651374 7651375 7651376 7651377 7651380 7651381 7651382 7651383 7651384 7651386 7651388 7651389 7651390 7651391 7651392 7651393 7651395 7651396 7651398 7651529 7651530 7651532 7651533 7651534 7651535 7651536 7651537 7651539 7651540 7651541 7651543 7651544 7651545 7651546 7651547 7651548 7651551 7651552 7651554 7651556 7651557 7651559 7651560 7651561 7651562 7651563 7651566 7651567 7651568 7651569 7651570 7651571 7651572 7651573 7651574 7651575 7651576 7651577 7651578 7651581 7651582 7651583 7651584 7651585 7651586 7651587 7651588 7651589 7651590 7651592 7651593 7651595 7651596 7651597 7651598 7651669 7651673…
FDA’s list runs to 761,031 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 761,031 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.