Thoratec recalls Heartmate 3 LVAS Implant Kit and Heartmate XVE/II Apical Coring Knives due to inadequate sharpness causing extended surgery time. Affected units have specific serial numbers.
Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.
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Contact the company
📍Recalling firmThoratec Corp.6035 Stoneridge Dr · Pleasanton, CA 94588-3270
“Thoratec Heartmate 3 LVAS Implant Kit and Apical Coring Knife Recall: Inadequate Sharpness.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57532-thoratec-heartmate-3-lvas-implant-kit-and-apical-coring-knife. Based on FDA recall #Z-2658-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2658-2023%22&limit=1).
The FDA announced on 2023-08-07 that Thoratec Corp. is recalling Heartmate 3 LVAS Implant Kits and Heartmate XVE & HeartMate II Apical Coring Knives due to inadequate sharpness that could extend surgical time. The agency classified the recall as Class II.
The inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife could result in an extended procedure or surgical time while the backup coring knife is acquired, according to the FDA.
Context
GovInfoNow's records show Thoratec Corp. has had 8 other recalls on record since 2019-03-01. Recent Thoratec recalls include a 2024-05-08 HeartMate Monitor Recall for screen errors and a 2024-03-01 HeartMate 3 LVAS Implant Kit Recall for potential seal leak risk. Other recent recalls of similar products include Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (2026-03-03), Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall (2026-07-09) and Kii Low Profile Bladed Dual Pack Recall (2025-12-11).
How to tell if you have this one
Check if your Heartmate 3 LVAS Implant Kit has serial numbers starting with MLP-034137 to MLP-037708 or MLP-038104 to MLP-039999. The Apical Coring Knife has serial numbers from 132849 to 135062.
Brand
Thoratec
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Verify your Heartmate 3 LVAS Implant Kit or Apical Coring Knife has the specific serial numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 40 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution including in the states of 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 the…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Check your serial numbers against the list provided in the recall notice. If you have the affected serial numbers, contact Thoratec for further instructions.
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-2658-2023 (August 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2658-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.