HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.
Recall
- Recall Number
- Z-1301-2024
- Event Number
- 93963
- Firm
- Thoratec Corp.
- FEI Number
- 2916596
- Product Code
- DSQ
- Status
- Open, Classified
- Root Cause
- Material/Component Contamination
- Initiated
- February 19, 2024
- Posted
- March 22, 2024
- Address
- 6035 Stoneridge Dr, Pleasanton, CA, 94588-3270
Description
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
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.
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