St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is…
Medical device recall Z-2334-2018. Published in FDA’s Enforcement Report on Jul 11, 2018.
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 Jul 11, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 42 states named
- 986 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?
The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
986, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI # 05415067027320, serial #: 3183655 3184443 3184389 3199068 3196286 3184694 3190294 3181655 3198025 3190799 3194537 3180006 3192949 3186903 3187101 3196843 3196904 3192584 3197571 3200146 3196834 3199504 3196786 3196805 3195788 3190818…
Every code shown here, 2,000 characters
UDI # 05415067027320, serial #: 3183655 3184443 3184389 3199068 3196286 3184694 3190294 3181655 3198025 3190799 3194537 3180006 3192949 3186903 3187101 3196843 3196904 3192584 3197571 3200146 3196834 3199504 3196786 3196805 3195788 3190818 3188329 3201060 3199511 3181484 3198003 3204372 3204525 3204636 3180578 3192047 3197501 3196979 3204026 3190151 3197910 3199061 3187666 3187623 3187958 3199534 3187579 3183988 3191662 3191694 3189471 3189447 3193462 3184495 3182230 3190806 3198544 3195797 3193022 3192891 3186926 3200949 3193007 3199057 3202523 3197153 3193232 3190810 3172363 3190533 3181685 3200755 3195794 3194101 3184565 3198525 3198218 3179589 3193169 3198440 3200149 3182632 3192996 3191110 3190276 3187652 3192050 3193294 3198473 3193374 3182618 3192025 3197500 3195597 3181067 3202827 3180032 3184390 3191088 3199082 3193190 3179542 3196379 3191707 3192522 3192553 3192345 3197952 3201029 3161789 3187614 3192147 3188632 3191329 3192939 3169502 3188423 3198315 3203609 3200671 3203015 3188910 3194498 3200326 3200106 3199163 3188056 3187944 3188081 3180424 3187896 3183112 3180411 3180333 3196930 3187911 3200372 3200308 3187942 3200094 3187574 3187865 3190815 3193199 3187644 3193357 3175355 3178902 3175364 3178951 3178901 3178930 3175392 3190350 3190247 3190365 3184431 3183961 3184510 3184469 3181199 3203028 3193368 3195841 3189780 3188014 3188002 3187994 3191638 3192655 3183842 3184833 3188947 3187854 3186463 3202568 3200110 3186835 3194057 3182576 3188893 3188949 3183736 3189830 3188397 3183298 3169553 3192408 3196839 3188074 3179533 3204035 3188345 3199121 3182188 3194508 3178945 3175377 3178995 3175385 3191413 3188872 3188848 3190819 3188671 3199619 3179537 3196827 3193863 3182617 3181191 3200675 3200704 3197593 3200461 3194557 3200849 3191426 3200412 3191597 3203296 3193273 3200376 3203303 3198182 3193262 3197751 3197989 3192400 3198486 3187881 3197591 3182224 3184994 3197537 3182939 3194558 3199573 3179603 3187637 3182965 3200340 3200930 3202082 3188422 3197729…
FDA’s list runs to 7,903 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.
U.S. Nationwide Distribution: PR, MI, NJ, IL, FL, AR, PA, KY, CA, TN, IN, AL, TX, AZ, SC, OK, VA, NH, NM, WA, CO, IA, WI, NV, UT, OH, NC, MO, DE, WV, MD, OR, NE, VT, KS, MA, IA, WY, CT, GA, MS, LA, DC, LA,
The states and territories these words name
42 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Missouri
- Mississippi
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- 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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Apr 16, 2018.
- FDA classified it on Jun 29, 2018.
- FDA’s Enforcement Report published it on Jul 11, 2018.
- FDA terminated it on Feb 4, 2021.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 7,903 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.