Thoratec Corp. Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
Brand
Thoratec Corp.
Lot Codes / Batch Numbers
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, 135060, 135061, 135062, 134247, 132849-132853, 134239, Apical Coring Knife Distributed Separately Serial Number Range: 132849 to 135062
Products Sold
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, 135060, 135061, 135062, 134247, 132849-132853, 134239; Apical Coring Knife Distributed Separately Serial Number Range: 132849 to 135062
Thoratec Corp. is recalling Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring K due to Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 8/7/23 customers were notified of the recall verbally, via email, in person visits, and phone calls. 8/21/23 the Abbott sales representatives started hand delivering correction notices to customers were told the firm was reinforcing the following warning in the Instructions for Use: 1) During the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in the event of an emergency. 2) Additionally, if unusual resistance is encountered during the coring procedure, immediately stop coring and complete using the backup Apical Coring Knife. Customers were also informed that in cases were the recall issue occurred during use, the physician was able to complete the procedure by using an Apical Coring Knife from the backup LVAS implant kit or an alternate surgical tool. Distribute this notice to those who need to be aware within your institution. Firm is continuing its investigation on this matter and working diligently to resume normal supply. Direct questions to your local Abbott representative. Complete and return the acknowledgement form via email to MCSHMNotices@Abbott.com Correction notices are continuing to be distributed identifying additional affected serial numbers. The firm is continuing to work with the apical coring knife vendor to supply knives that do not present this issue. However, the supply of unaffected apical coring knives continues to be limited.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026