Thoratec HeartMate 3, LVAS Implant Kit
Medical device recall Z-1692-2024. Published in FDA’s Enforcement Report on May 8, 2024.
- 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 8, 2024. 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 41 states named
- 882 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 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?
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
882 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 00813024013297/Serial Number: MLP-026628 MLP-026733 MLP-026929 MLP-027005 MLP-027322 MLP-027363 MLP-027387 MLP-027390 MLP-027596 MLP-027678 MLP-027879 MLP-028290 MLP-028518 MLP-028665 MLP-028754 MLP-028931 MLP-029026 MLP-029108…
Every code shown here, 1,993 characters
UDI: 00813024013297/Serial Number: MLP-026628 MLP-026733 MLP-026929 MLP-027005 MLP-027322 MLP-027363 MLP-027387 MLP-027390 MLP-027596 MLP-027678 MLP-027879 MLP-028290 MLP-028518 MLP-028665 MLP-028754 MLP-028931 MLP-029026 MLP-029108 MLP-029187 MLP-029304 MLP-029368 MLP-029462 MLP-029473 MLP-029656 MLP-029682 MLP-029686 MLP-029845 MLP-030174 MLP-030180 MLP-030215 MLP-030216 MLP-030844 MLP-030945 MLP-030993 MLP-031350 MLP-031430 MLP-031507 MLP-031529 MLP-031710 MLP-031725 MLP-031780 MLP-032045 MLP-032092 MLP-032194 MLP-032302 MLP-032534 MLP-032794 MLP-032917 MLP-032926 MLP-032952 MLP-033026 MLP-033232 MLP-033394 MLP-033541 MLP-033633 MLP-033799 MLP-033829 MLP-033875 MLP-033905 MLP-033948 MLP-033960 MLP-033981 MLP-034050 MLP-034055 MLP-034059 MLP-034089 MLP-034090 MLP-034098 MLP-034135 MLP-034144 MLP-034184 MLP-034266 MLP-034380 MLP-034582 MLP-034594 MLP-034719 MLP-034721 MLP-034724 MLP-034816 MLP-034821 MLP-034835 MLP-034877 MLP-034879 MLP-034883 MLP-034926 MLP-035031 MLP-035032 MLP-035098 MLP-035148 MLP-035177 MLP-035386 MLP-035387 MLP-035510 MLP-035528 MLP-035588 MLP-035609 MLP-035613 MLP-035691 MLP-035700 MLP-035925 MLP-035931 MLP-036123 MLP-036166 MLP-036173 MLP-036254 MLP-036298 MLP-036367 MLP-036413 MLP-036644 MLP-036749 MLP-036797 MLP-036815 MLP-036831 MLP-036872 MLP-037066 MLP-037152 MLP-037213 MLP-037396 MLP-037436 MLP-037470 MLP-037517 MLP-037702 MLP-037746 MLP-037758 MLP-037792 MLP-037867 MLP-037928 MLP-037939 MLP-037945 MLP-038129 MLP-038147 MLP-038156 MLP-038281 MLP-038325 MLP-038467 MLP-038696 MLP-038743 MLP-038783 MLP-038791 MLP-038796 MLP-038858 MLP-038941 MLP-038942 MLP-039006 MLP-039012 MLP-039039 MLP-039051 MLP-039071 MLP-039257 MLP-039346 MLP-039406 MLP-039423 MLP-039450 MLP-039464 MLP-039465 MLP-039471 MLP-039483 MLP-039492 MLP-039496 MLP-039515 MLP-039522 MLP-039534 MLP-039590 MLP-039629 MLP-039635 MLP-039636 MLP-039638 MLP-039651 MLP-039679 MLP-039680 MLP-039681 MLP-039687 MLP-039718 MLP-039721 MLP-039723 MLP-039764 MLP-039770 MLP-039799…
FDA’s list runs to 9,736 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: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, & WV; and OUS (foreign) countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, Colombia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, and Uzbekistan.
The states and territories these words name
41 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
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
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 1, 2024.
- FDA classified it on May 1, 2024.
- FDA’s Enforcement Report published it on May 8, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Thoratec Corp., of Pleasanton, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
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 9,736 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.