HeartMate II Left Ventricular Assist System (LVAS): 1
Medical device recall Z-1300-2024. 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
- 2,240 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 II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II LVAS Implant Kit, OUS REF 102139 2. HeartMate II LVAS Implant Kit, US REF 1355 3. HeartMate II LVAS Implant Kit (with RSOC Controller), US REF 103695 4. HeartMate II LVAS Implant Kit (with RSOC Controller), OUS REF 103693 5. HeartMate II LVAS Implant Kit (with Sealed Graft), US REF 104911 6. HeartMate II LVAS Implant Kit (with Sealed Graft), OUS REF 104912 7. HeartMate II LVAS Implant Kit (Used for pump exchange, No Graft) REF 107801 8. HeartMate II LVAS Implant Kit, (EPC), CANADA REF 103695-CAN 9. HeartMate II LVAS Implant Kit (with Sealed Graft), JAPAN REF 104911JPN 10. HeartMate II LVAS Implant Kit (with Pocket System Controller and Sealed Grafts), for geographies outside of US & EU REF 106515OUS HeartMate II Left Ventricular Assist System: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system. One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries.
2,240 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
HeartMate II LVAS Model Numbers: 1. 103393 (cannot be implanted without a LVAD) 2. 106015 (US) 3. 106016 (OUS) Update (February 14, 2024) HeartMate II LVAS: 1. 102139 (OUS), includes Unsealed Outflow Graft with Bend Relief 2. 1355 (US),…
Every code shown here, 1,995 characters
HeartMate II LVAS Model Numbers: 1. 103393 (cannot be implanted without a LVAD) 2. 106015 (US) 3. 106016 (OUS) Update (February 14, 2024) HeartMate II LVAS: 1. 102139 (OUS), includes Unsealed Outflow Graft with Bend Relief 2. 1355 (US), includes Unsealed Outflow Graft with Bend Relief 3. 103695 (US), includes Unsealed Outflow Graft with Bend Relief 4. 103693 (OUS), includes Unsealed Outflow Graft with Bend Relief 5. 104911 (US) 6. 104912 (OUS) 7. 107801 (US), does not include Outflow Graft 8. 103695-CAN, includes Unsealed Outflow Graft with Bend Relief 9. 104911JPN 10. 106515OUS UDI-DI codes: HeartMate II LVAS: 1. 00813024010807 2. 00813024011224 3. 00813024011231 Update (February 14, 2024) HeartMate II LVAS: 1. N/A 2. 00813024010005 3. 00813024010616 4. 00813024010623 5. 00813024011170 6. 00813024010821 7. 00813024011996 8. N/A 9. 00813024011682 10. 00813024011682 Serial Numbers: US VAD-0357 VAD-0638 VAD-10113 VAD-10162 VAD-10198 VAD-10418 VAD-10543 VAD-10634 VAD-10708 VAD-10734 VAD-10749 VAD-10808 VAD-10840 VAD-10995 VAD-11099 VAD-11104 VAD-11131 VAD-11134 VAD-11241 VAD-11250 VAD-11343 VAD-11369 VAD-11488 VAD-11545 VAD-11602 VAD-11866 VAD-11937 VAD-12055 VAD-12075 VAD-12169 VAD-12174 VAD-12280 VAD-12333 VAD-12344 VAD-12440 VAD-12449 VAD-12454 VAD-12516 VAD-12622 VAD-12641 VAD-12644 VAD-12690 VAD-12756 VAD-12806 VAD-12909 VAD-12943 VAD-13002 VAD-13011 VAD-13094 VAD-13096 VAD-13148 VAD-13161 VAD-13171 VAD-13232 VAD-13263 VAD-13304 VAD-13385 VAD-13388 VAD-13416 VAD-13464 VAD-13488 VAD-13543 VAD-13568 VAD-13586 VAD-13639 VAD-13647 VAD-13725 VAD-13735 VAD-13797 VAD-13844 VAD-13862 VAD-13896 VAD-13914 VAD-13915 VAD-13922 VAD-13924 VAD-13961 VAD-13988 VAD-13993 VAD-14038 VAD-14104 VAD-14176 VAD-14179 VAD-14235 VAD-14261 VAD-14304 VAD-14312 VAD-14336 VAD-14347 VAD-14383 VAD-14387 VAD-14456 VAD-14480 VAD-14493 VAD-14507 VAD-14511 VAD-14525 VAD-14534 VAD-14535 VAD-14562 VAD-14576 VAD-14578 VAD-14662 VAD-14690 VAD-14699 VAD-14706 VAD-14743 VAD-14752 VAD-14775 VAD-14778…
FDA’s list runs to 23,164 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 23,164 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.