Use caution Medical device recall · FDA · Published March 30, 2019

Thoratec Heartmate 3 Outflow Graft Recall: Leaking During Implantation

Thoratec recalls Heartmate 3 Sealed Outflow Graft with Bend Relief for potential leaking during implantation. If the C-Ring isn't seated properly, the device may not function during surgery.

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

🇺🇸 FDA recall #Z-2349-2019Medical device Thoratec ›

Use caution until it’s fixed

Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Thoratec is recalling Heartmate 3 Sealed Outflow Graft parts that could leak during implantation if the C-Ring isn't properly seated. This could cause the device to malfunction during surgery, putting patients at risk. Read more at govinfonow.com/recall/68526-thoratec-heartmate-3-outflow-graft-recall-leaking-during-implantation.

Source Summary by GovInfoNow · govinfonow.com/recall/68526-thoratec-heartmate-3-outflow-graft-recall-leaking-during-implantation · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2349-2019

Cite this page

“Thoratec Heartmate 3 Outflow Graft Recall: Leaking During Implantation.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68526-thoratec-heartmate-3-outflow-graft-recall-leaking-during-implantation. Based on FDA recall #Z-2349-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2349-2019%22&limit=1).

The FDA announced on March 30, 2019, that Thoratec Corp. is recalling the Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief due to a leaking hazard at the pump connection during implantation. The agency issued recall number Z-2349-2019 for the Class II device.

How to tell if you have it

Brand: Thoratec
Product: Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile
REF: 105581US/105581
Part of Left Ventricular Assist Device (LVAD)
UDI: 00813024013266
GMDN: 61747
Lot numbers: 6613000 and below or 50000000 and higher
Quantity: 149 units

The hazard

The outflow graft may leak at the pump connection during the implantation process if the C-Ring is insufficiently seated. This condition renders the device nonfunctional because the connection will leak during the procedure.

Context

GovInfoNow's records show Thoratec Corp. has had 8 other recalls on record since March 1, 2019. Recent Thoratec recalls include a May 8, 2024 HeartMate Monitor recall for screen errors and a March 1, 2024 HeartMate 3 LVAS Implant Kit recall for potential seal leaks. Other recent recalls of similar products include an August 20, 2026 ICU Medical CADD Yellow Medication Cassette Reservoir recall for leakage risk and a June 11, 2026 Abiomed Heart Pump Kit recall for introducer sheath leakage risk.

How to tell if you have this one

Check for the part number REF 105581US/105581 on the device. The UDI is 00813024013266 or batch numbers 6613000 and below or 50000000 and higher.

Brand
Thoratec
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Worldwide distribution. US nationwide, Australia, Austria, Brazil, Canada, Cayman Islands, Chile, Colombia, Egypt, France, Germany, Greece, Singapore, Iran, Italy, Kuwait, Lebanon, Romania, Switzerland, Thailand, United Kingdom.

Recall number	Product, codes & lots	Quantity
Z-2348-2019	Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System; 106524/106524US: The shelf life is 36 months from date of manufacture. All batch/lot numbers 6613000 or 50000000 or higher. UDI/GMDN 00813024013297 / 47533	7200 left ventricular assist systems
Z-2349-2019	Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266; 105581/105581US: The shelf life is 60 months from date of manufacture. All batch/lot numbers 6613000 and below or 50000000 and higher. UDI/GMDN 00813024013266 / 61747	149 outflow graft units

Based on the official FDA remedy

What to do — step by step

Check Device Details
Look for the part number REF 105581US/105581 and UDI 00813024013266 on the device.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution. US nationwide, Australia, Austria, Brazil, Canada, Cayman Islands, Chile, Colombia, Egypt, France, Germany, Greece, Singapore, Iran, Italy, Kuwait, Lebanon, Romania, Switzerland, Thailand, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Mar 30, 2019Firm started the recall
Aug 22, 2019FDA classified it Class II
Aug 28, 2019Published in FDA’s Enforcement Report
Aug 24, 2020FDA 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/68526-thoratec-heartmate-3-outflow-graft-recall-leaking-during-implantation">Thoratec Heartmate 3 Outflow Graft Recall: Leaking During Implantation (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-2349-2019 (March 30, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2349-2019 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.