Thoratec HeartMate 3 LVAS Implant Kit
Medical device recall Z-1774-2018. Published in FDA’s Enforcement Report on May 23, 2018.
- 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 23, 2018. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- 35 states named in where it went
- 5,607 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?
Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
5,607, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
United States: UDI: 00813024013297, Serial Numbers: MLP 000976, MLP 000989, MLP 000991, MLP 000999, MLP 001002, MLP 002020, MLP 002041, MLP 002048, MLP 002049, MLP 002056, MLP 002057, MLP 002058, MLP 002059, MLP 002066, MLP 002069, MLP…
Every code shown here, 2,000 characters
United States: UDI: 00813024013297, Serial Numbers: MLP 000976, MLP 000989, MLP 000991, MLP 000999, MLP 001002, MLP 002020, MLP 002041, MLP 002048, MLP 002049, MLP 002056, MLP 002057, MLP 002058, MLP 002059, MLP 002066, MLP 002069, MLP 002070, MLP 002071, MLP 002072, MLP 002074, MLP 002075, MLP 002076, MLP 002080, MLP 002082, MLP 002084, MLP 002087, MLP 002088, MLP 002090, MLP 002091, MLP 002093, MLP 002096, MLP 002117, MLP 002118, MLP 002119, MLP 002120, MLP 002121, MLP 002123, MLP 002124, MLP 002125, MLP 002126, MLP 002127, MLP 002128, MLP 002130, MLP 002132, MLP 002133, MLP 002134, MLP 002135, MLP 002136, MLP 002137, MLP 002141, MLP 002144, MLP 002152, MLP 002155, MLP 002156, MLP 002157, MLP 002158, MLP 002159, MLP 002160, MLP 002162, MLP 002163, MLP 002161, MLP 002164, MLP 002165, MLP 002188, MLP 002189, MLP 002191, MLP 002192, MLP 002197, MLP 002198, MLP 002200, MLP 002201, MLP 002203, MLP 002204, MLP 002205, MLP 002206, MLP 002207, MLP 002208, MLP 002209, MLP 002211, MLP 002213, MLP 002214, MLP 002216, MLP 002217, MLP 002218, MLP 002219, MLP 002220, MLP 002221, MLP 002222, MLP 002223, MLP 002224, MLP 002226, MLP 002227, MLP 002228, MLP 002229, MLP 002236, MLP 002237, MLP 002238, MLP 002239, MLP 002240, MLP 002241, MLP 002243, MLP 002244, MLP 002245, MLP 002246, MLP 002247, MLP 002248, MLP 002250, MLP 002251, MLP 002254, MLP 002253, MLP 002255, MLP 002257, MLP 002258, MLP 002259, MLP 002261, MLP 002263, MLP 002264, MLP 002266, MLP 002267, MLP 002268, MLP 002269, MLP 002271, MLP 002272, MLP 002273, MLP 002274, MLP 002275, MLP 002276, MLP 002277, MLP 002278, MLP 002280, MLP 002281, MLP 002282, MLP 002283, MLP 002285, MLP 002286, MLP 002287, MLP 002288, MLP 002289, MLP 002290, MLP 002291, MLP 002292, MLP 002293, MLP 002294, MLP 002295, MLP 002300, MLP 002303, MLP 002304, MLP 002306, MLP 002307, MLP 002308, MLP 002309, MLP 002310, MLP 002311, MLP 002312, MLP 002314, MLP 002315, MLP 002316, MLP 002317, MLP 002318, MLP 002319, MLP 002320, MLP 002321, MLP 002324, MLP…
FDA’s list runs to 67,366 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., including the states of MN, PA, IL, WI, AZ, AR, TN, MO, TX, MA, NE, MI, CA, NC, OH, NY, GA, VA, FL, OK, MD, ME, SC, IN, LA, OR, WA, AL, CO, IA, KS, KY, UT, DC, and CT; and, the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, Cayman Islands, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Kuwait, Lebanon, Malaysia, Montenegro, Netherlands, Poland, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
The states and territories these words name
35 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- North Carolina
- Nebraska
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
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 Apr 5, 2018.
- FDA classified it on May 16, 2018.
- FDA’s Enforcement Report published it on May 23, 2018.
- FDA terminated it on Oct 15, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abbott, 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 67,366 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.