HeartMate 3 Left Ventricular Assist System (LVAS): 1
Medical device recall Z-1301-2024. Published in FDA’s Enforcement Report on Mar 27, 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 Mar 27, 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 42 states named
- 22,663 kits 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?
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.
22,663 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
HeartMate 3 LVAS Model Numbers: 1. 105581 (IDE, cannot be implanted without a Left Ventricular Assist Device (LVAD)) 2. 105581US (cannot be implanted without a LVAD) 3. 105581INT (cannot be implanted without a LVAD) 4. 106524 (IDE) 5.…
Every code shown here, 1,996 characters
HeartMate 3 LVAS Model Numbers: 1. 105581 (IDE, cannot be implanted without a Left Ventricular Assist Device (LVAD)) 2. 105581US (cannot be implanted without a LVAD) 3. 105581INT (cannot be implanted without a LVAD) 4. 106524 (IDE) 5. 106524US 6. 106524INT UDI-DI codes: HeartMate 3 LVAS: 1. N/A (IDE) 2. 00813024013266 3. 00813024011675 4. N/A (IDE) 5. 00813024013297 6. 00813024011712 Serial Numbers: For Model 106524 US MLP-000991 MLP-002058 MLP-002066 MLP-002069 MLP-002070 MLP-002076 MLP-002117 MLP-002126 MLP-002128 MLP-002133 MLP-002136 MLP-002152 MLP-002158 MLP-002159 MLP-002160 MLP-002164 MLP-002165 MLP-002191 MLP-002192 MLP-002197 MLP-002206 MLP-002208 MLP-002216 MLP-002217 MLP-002239 MLP-002241 MLP-002246 MLP-002251 MLP-002254 MLP-002259 MLP-002263 MLP-002268 MLP-002269 MLP-002278 MLP-002288 MLP-002289 MLP-002291 MLP-002294 MLP-002300 MLP-002304 MLP-002309 MLP-002310 MLP-002316 MLP-002318 MLP-002321 MLP-002324 MLP-002337 MLP-002342 MLP-002347 MLP-002355 MLP-002356 MLP-002361 MLP-002365 MLP-002450 MLP-002455 MLP-002456 MLP-002472 MLP-002475 MLP-002510 MLP-002514 MLP-002518 MLP-002519 MLP-002520 MLP-002530 MLP-002536 MLP-002538 MLP-002539 MLP-002543 MLP-002589 MLP-002597 MLP-002603 MLP-002633 MLP-002643 MLP-002646 MLP-002650 MLP-002654 MLP-002660 MLP-002663 MLP-002666 MLP-002805 MLP-002807 MLP-002808 MLP-002809 MLP-002827 MLP-002828 MLP-002838 MLP-002840 MLP-002842 MLP-002844 MLP-002850 MLP-002858 MLP-002957 MLP-003028 MLP-003033 MLP-003057 MLP-003058 MLP-003068 MLP-003070 MLP-003072 MLP-003074 MLP-003077 MLP-003085 MLP-003086 MLP-003089 MLP-003097 MLP-003110 MLP-003114 MLP-003125 MLP-003130 MLP-003131 MLP-003140 MLP-003148 MLP-003186 MLP-003237 MLP-003255 MLP-003257 MLP-003259 MLP-003277 MLP-003291 MLP-003299 MLP-003300 MLP-003302 MLP-003307 MLP-003308 MLP-003314 MLP-003317 MLP-003340 MLP-003347 MLP-003348 MLP-003351 MLP-003352 MLP-003384 MLP-003385 MLP-003388 MLP-003389 MLP-003390 MLP-003441 MLP-003442 MLP-003461 MLP-003466 MLP-003469 MLP-003471 MLP-003571…
FDA’s list runs to 249,778 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): 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, VT, WA, WI, and WV; and O.U.S.(foreign) to countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Island, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Libya, Liechtenstein, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and South Korea.
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
- 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
- Vermont
- 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 Feb 19, 2024.
- FDA classified it on Mar 21, 2024.
- FDA’s Enforcement Report published it on Mar 27, 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: 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 249,778 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.