Unrated Medical device recall · FDA · Published March 1, 2019

Thoratec HeartMate 3 Coring Tool Recall: Small Plastic Particle Risk

Thoratec recalls HeartMate 3 Coring Tool (REF 10005872) due to small black plastic particles found in left ventricle during implant. Affected units have specific lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1203-2019Medical device Thoratec ›

Recall notice

Small black plastic particle was observed in the left ventricle during implant procedure.

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Contact the company

Recalling firmThoratec Corp.6035 Stoneridge Dr · Pleasanton, CA 94588-3270

✎ GovInfoNow plain-language explainer

Thoratec is recalling its HeartMate 3 Coring Tool (REF 10005872) because small black plastic particles were observed in the left ventricle during implant procedures. This could pose a risk to patients using the device. Read more at govinfonow.com/recall/68917-thoratec-heartmate-3-coring-tool-recall-small-plastic-particle-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/68917-thoratec-heartmate-3-coring-tool-recall-small-plastic-particle-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1203-2019

Cite this page

“Thoratec HeartMate 3 Coring Tool Recall: Small Plastic Particle Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68917-thoratec-heartmate-3-coring-tool-recall-small-plastic-particle-risk. Based on FDA recall #Z-1203-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1203-2019%22&limit=1).

The FDA announced on March 1, 2019, that Thoratec Corp. recalled the Thoratec HeartMate 3 Coring Tool due to a hazard where small black plastic particles were observed in the left ventricle during implant procedures. The agency issued recall number Z-1203-2019 for this Class II voluntary recall.

How to tell if you have it

Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only
REF 10005872
Lot Numbers: 6675594, 6675724, 6675730, 6677921, 6696569, 6696580, 6696582, 6696597, 6696601, 6696604, 6703553, 6703561, 6703563, 6703567, 6721603, 6721660, 6721661, 6721663, 6721671, 6721672, 6721673, 193496, 193497, 193499, 193501, 6425740, 6425773, 6449684, 6675597, 6449680, 6425751, 6425758, 6425763, 6425768, 6449657, 6449662, 6512124, 6677922, 6425756, 6425766, 6425770, 6449675, 6449681, 6449691, 6675592, 6677919, 6677926, 6694918, 6696574, 193500, 193502, 6425745, 6425776, 6449663, 6449664, 6449679, 6449682, 6449687, 6449689, 6677924, 6677927, 6692906, 6693957, 6696589, 193495, 193498, 6449692, 6675591, 6675596, 6692904, 6696599, 6512126, 6675732, 6675734, 6675736, 6692897, 6449677, 6692877

The hazard

According to the FDA, a small black plastic particle was observed in the left ventricle during the implant procedure. The recall addresses this specific hazard associated with the optional accessory of the Thoratec HeartMate 3 Left Ventricular Assist System.

Context

GovInfoNow's records show Thoratec Corp. has 8 other recalls on record since March 30, 2019. Recent Thoratec recalls include a May 8, 2024 recall for screen errors and a March 1, 2024 recall for potential leak paths at the seal interface. Other recent recalls of similar products include a Medline Heart Cath Pack-LF Kits Recall (March 24, 2026) and an AVID Medical Halyard Kits Recall (April 30, 2026).

How to tell if you have this one

Check if your HeartMate 3 Left Ventricular Assist System has the coring tool with lot numbers: 6675594, 6675724, 6675730, and other numbers listed in the recall. The product is an optional accessory for the HeartMate 3 Left system.

Brand
Thoratec
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Identify if your HeartMate 3 Coring Tool has one of the listed lot numbers: 6675594, 6675724, 6675730, or other specific numbers provided in the recall.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 16 states.

FDA distribution: “US Nationwide distribution in the states of MN, WI, TX, NC, GA, OK, UT, NY, SC, IL, LA, MI, IN, CA, OH, WA. Foreign (OUS): AUSTRIA, BELGIUM, CANADA, ESTONIA, FRANCE, GERMANY, GREECE, INDIA, ITALY, KUWAIT, LIECHTENSTEIN, LITHUANIA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Georgia, Illinois, Indiana, Louisiana, Michigan, Minnesota, New York, North Carolina, Ohio, Oklahoma, South Carolina, Texas, Utah, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 3.4 years after the firm started it.

Mar 1, 2019Firm started the recall
Apr 19, 2019FDA classified it Class II
May 1, 2019Published in FDA’s Enforcement Report
Aug 10, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/68917-thoratec-heartmate-3-coring-tool-recall-small-plastic-particle-risk">Thoratec HeartMate 3 Coring Tool Recall: Small Plastic Particle Risk (GovInfoNow)</a>

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-1203-2019 (March 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1203-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.