Abbott Thoratec HeartMate 3 LVAS Implant Kit Recall: Outflow Graft Twist Occlusions Risk
Abbott recalls Thoratec HeartMate 3 LVAS Implant Kits (Rx Only) with serial numbers starting MLP 000976 due to reports of outflow graft twist occlusions causing persistent low flow alarms and serious health risks including hemodynamic compromise, thrombus, and death.
Stop using this now
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.
Contact the company
What happened, in plain English
Abbott is recalling Thoratec HeartMate 3 LVAS Implant Kits (Rx Only) with specific serial numbers because reports indicate these devices can twist and block the outflow graft, triggering persistent low flow alarms. This can lead to serious health issues like heart failure, blood clots, or death if not addressed. Read more at govinfonow.com/recall/71540-abbott-thoratec-heartmate-3-lvas-implant-kit-recall-outflow-graft.
Source Summary by GovInfoNow · govinfonow.com/recall/71540-abbott-thoratec-heartmate-3-lvas-implant-kit-recall-outflow-graft · Updated September 23, 2026 · FDA enforcement record: FDA #Z-1774-2018
Cite this page
“Abbott Thoratec HeartMate 3 LVAS Implant Kit Recall: Outflow Graft Twist Occlusions Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/71540-abbott-thoratec-heartmate-3-lvas-implant-kit-recall-outflow-graft. Based on FDA recall #Z-1774-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1774-2018%22&limit=1).
Why it’s dangerous
The outflow graft in the device can twist and become occluded (blocked), causing persistent low flow alarms. This blockage can lead to serious health events such as hemodynamic compromise (inadequate blood flow), blood clots, or death if the issue is not resolved.
Who’s affected
Patients with the recalled HeartMate 3 LVAS Implant Kits (Rx Only) who have the specific serial numbers listed in the recall. Those with the device are at highest risk as the issue can cause life-threatening complications.
How to tell if you have this one
Check if your HeartMate 3 LVAS Implant Kit (Rx Only) has serial numbers starting with MLP followed by numbers like 000976, 000989, 000991, and the other listed serial numbers in the recall. The device is indicated for short-term hemodynamic support in patients with advanced heart failure.
- Brand
Thoratec- Category
Medical device
What to do — step by step
Stop using it now
Immediately stop using the HeartMate 3 LVAS Implant Kit if it has the recalled serial numbers listed in the recall.
Where it went and when
Where it was distributed
Distributed in 34 states and D.C., and outside the U.S.
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1774-2018 (April 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1774-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.