Recall Z-2658-2023— Thoratec Corp.

Name: FDA recall Z-2658-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-07

Class II · Ongoing

Class II FDA medical device recall by Thoratec Corp., initiated 2023-08-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050. Reason: 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..

Recalling firm: Thoratec Corp.
Classification: Class II
Status: Ongoing
Initiated: 2023-08-07
Firm location: Pleasanton, CA, United States

Product description

Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.