HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2.

FDA device recall Z-1300-2024 · posted 2024-03-22 · Open, Classified

Recall details

Recalling firm

Thoratec Corp.

Reason for recall

Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

Action taken

On 02/19/2024, the firm will hand deliver an "URGENT MEDICAL DEVICE CORRECTION" Letter to customers that informs them of Abbott's planned update to Instructions for Use associated with observations of outflow graft deformation known as "Extrinsic Outflow Graft Obstruction" (EOGO) associated with the HeartMate 3 and HeartMate II Left Ventricular Assist Systems (LVAS) which may manifest clinically as a persistent low flow alarm under certain circumstances in some patients and may impair the ability of the LVAS to provide adequate hemodynamic support. Guidance and Recommendations: Continue to pay attention to low flow alarms, the first symptom of significant outflow obstruction. -The following information provides guidance on how to diagnose unresolved low flow associated with outflow graft obstruction and recommended actions. A clinical article published in 2018 (Mehra et al. J Heart Lung Transplant. 2018 Nov;37(11):1281-1284.) includes a suggested diagnostic algorithm to recognize outflow graft obstruction for HeartMate 3 LVAD in the context of outflow graft twist. This published approach is appropriate to determine if significant EOGO is present and contributing to observed low flow alarms that are not able to be resolved." If the patient presents with symptoms such as a trend to reduced flow with no improvement back to baseline or persistent low flow alarms (with or without symptoms), the first step is to rule out other clinical conditions that could cause low flow. " If the patient signs or symptoms persist, it is important to rule out compression of the outflow graft through imaging such as a CT Angiogram. Abbott will update the Instructions for Use to include additional diagnostic recommendations and is in the process of developing and qualifying a design solution. for questions, contact Abbott Technical Support at 1-800-456-1477.

Root cause

Material/Component Contamination

Status

Open, Classified

Product code

DSQ

Quantity affected

2,240 kits

Distribution

Worldwide distribution: U.S.(nationwide): 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, TN, TX, UT, VA, VT, WA,

Date initiated

2024-02-19

Date posted

2024-03-22

Location

Pleasanton, CA