PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker…
Medical device recall Z-0038-2018. 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
- 2726 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?
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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
2726 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 4794381 4913465 4913480 4907866 4909681 4909682 4913495 4909675 4909680 4909677 4909674 4913482 4913489 4913487 4913472 4913458 4913133 4913137 4913477 4909678 4913469 4913459 4913498 4909347 4913492 4913139 4908522 4909679…
Every code shown here, 2,000 characters
Serial Numbers: 4794381 4913465 4913480 4907866 4909681 4909682 4913495 4909675 4909680 4909677 4909674 4913482 4913489 4913487 4913472 4913458 4913133 4913137 4913477 4909678 4913469 4913459 4913498 4909347 4913492 4913139 4908522 4909679 4909350 4909345 4909348 4909190 4909189 4909188 4909186 4909349 4908662 4909182 4909184 4909183 4909346 4909344 4909185 4909352 4909351 4909187 4913155 4913493 4913844 4913143 4913148 4913166 4913153 4913167 4913163 4913158 4913140 4913466 4913164 4913150 4913125 4913131 4913159 4913162 4913160 4913461 4913146 4913500 4915969 4915951 4915954 4915947 4915958 4915968 4915961 4915949 4913468 4915957 4913842 4913471 4913475 4913481 4913499 4913147 4913496 4913479 4913843 4913132 4915955 4913476 4913152 4913501 4913470 4913462 4913463 4913138 4913134 4913460 4913124 4913473 4913145 4913478 4913464 4913467 4913491 4913483 4913484 4913485 4913486 4913474 4913142 4913127 4913130 4913136 4913129 4913156 4913161 4913488 4913157 4913497 4913141 4913490 4913151 4913154 4913149 4913144 4913168 4913457 4913165 4913128 4913126 4913135 4883225 4880664 4837327 4838100 4837325 4838488 4793649 4796562 4796798 4796555 4796792 4796575 4796564 4796567 4796566 4796795 4794382 4838101 4838105 4837315 4886740 4837316 4838496 4793656 4841520 4794374 4794390 4794370 4838112 4794378 4802372 4793654 4795227 4796785 4869214 4799303 4867932 4867933 4867927 4838091 4886419 4801890 4886421 4802322 4886420 4886729 7896805 4838097 4886751 4801893 4837306 4839292 4838393 4839310 4886746 4801904 4838494 4798072 4838498 4886743 4838116 4838445 4886416 4886747 4801897 4839303 4838076 4885056 4798962 4797671 4799291 4799609 4799296 4838497 4867937 4880259 4880270 4880674 4798963 4884428 4796790 4885053 4884427 7873203 4885058 4885754 4884439 4885048 4836568 4838072 4880268 7896803 7896795 4799302 4838378 4837354 4837314 4841537 4842197 4838083 4869225 4838383 7896802 4836205 4836564 4838102 7873202 4869217 4836204 4887988 7873209 4883223 4883242 4883252 4883251 4883246…
FDA’s list runs to 21,824 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 21,824 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.