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

FDA device recall Z-2658-2023 · posted 2023-09-29 · Open, Classified

Recall details

Recalling firm

Thoratec Corp.

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

DSQ

Quantity affected

2,681

Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC

Date initiated

2023-08-07

Date posted

2023-09-29

Location

Pleasanton, CA