HeartMate Left Ventricular Assist Device Coring Knife Sharpness Defect
The Apical Coring Knife in HeartMate 3 Left Ventricular Assist System kits may be inadequately sharp, potentially extending surgical implantation time. Thoratec has distributed 2,681 affected units worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II FDA medical device recall affecting a surgical instrument used in life-sustaining cardiac implantation procedures. While no deaths or injuries have been reported, the defect in a critical surgical instrument that could extend operative time in cardiac surgery represents a risk-of-harm situation where injury has not yet been reported.
Plain-English summary
Thoratec Corp. is recalling 2,681 HeartMate 3 Left Ventricular Assist System Implant Kits and associated Apical Coring Knives due to inadequate sharpness of the surgical instrument.
The Apical Coring Knife is used during left ventricular assist device implantation surgery to perform the apical coring procedure. If the knife is inadequately sharp, it may be unable to properly start or complete this procedure, necessitating replacement with a backup coring knife and extending surgical time.
The affected devices include HeartMate 3 LVAS Implant Kits (REF: 106524US, 106524INT) and HeartMate XVE/II Apical Coring Knives (REF: 1050) with specific serial number ranges. Affected units have been distributed worldwide, including throughout the United States and to over 50 countries in Europe, Asia, the Middle East, Africa, and the Americas.
Patients and healthcare providers should contact Thoratec Corp. to determine if their device is affected and discuss appropriate options for verification or replacement.
The recalled product
- Product
- Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
- Manufacturer
- Thoratec Corp.
- Affected units
- 2,681
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI/Serial Numbers: 106524US/00813024013297/MLP-034137 to MLP-034744
- MLP-035485 to MLP-035714
- MLP-036330 to MLP-037708
- MLP-038104 to MLP-038999
- MLP-039000 to MLP-039999
- MLP-040000 to MLP-040999
- MLP-041000 to MLP-041621
- 106524INT/00813024011712 (OUS)/MLP-032482
- MLP-035542 to MLP-035667
- MLP-037218 to MLP-037527
- MLP-038008 to MLP-038989
- MLP-039014 to MLP-039945
- MLP-040009 to MLP-040896
- MLP-041013 to MLP-041589
- 1050/00813024010227: 135021-135025
- 134241-134246
- 134248
- 134250
- 134251
- 134240
Distribution
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