FDA Device recall Z-1301-2024

HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (…

FDA Device
Class I
ongoing
Published 2024-03-27

On 2024-03-27 the FDA classified a Class I recall of HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (… by Thoratec, citing observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1301-2024
Classification	Class I
Status	ongoing
Initiated	2024-02-19
Published	2024-03-27
Last updated	2026-09-13 11:57 UTC
Company	Thoratec
Distribution	US

Product

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.

Reason

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

Identifiers

code_info	HeartMate 3 LVAS Model Numbers: 1. 105581 (IDE, cannot be implanted without a Left Ventricular Assist Device (LVAD))… HeartMate 3 LVAS Model Numbers: 1. 105581 (IDE, cannot be implanted without a Left Ventricular Assist Device (LVAD)) 2. 105581US (cannot be implanted without a LVAD) 3. 105581INT (cannot be implanted without a LVAD) 4. 106524 (IDE) 5. 106524US 6. 106524INT UDI-DI codes: HeartMate 3 LVAS: 1. N/A (IDE) 2. 00813024013266 3. 00813024011675 4. N/A (IDE) 5. 00813024013297 6. 00813024011712 Serial Numbers: For Model 106524 US MLP-000991 MLP-002058 MLP-002066 MLP-002069 MLP-002070 MLP-002076 MLP-002117 MLP-002126 MLP-002128 MLP-002133 MLP-002136 MLP-002152 MLP-002158 MLP-002159 MLP-002160 MLP-002164 MLP-002165 MLP-002191 MLP-002192 MLP-002197 MLP-002206 MLP-002208 MLP-002216 MLP-002217 MLP-002239 MLP-002241 MLP-002246 MLP-002251 MLP-002254 MLP-002259 MLP-002263 MLP-002268 MLP-002269 MLP-002278 MLP-002288 MLP-002289 MLP-002291 MLP-002294 MLP-002300 MLP-002304 MLP-002309 MLP-002310 MLP-002316 MLP-002318 MLP-002321 MLP-002324 MLP-002337 MLP-002342 MLP-002347 MLP-002355 MLP-00

code_info

HeartMate 3 LVAS Model Numbers: 1. 105581 (IDE, cannot be implanted without a Left Ventricular Assist Device (LVAD))…

HeartMate 3 LVAS Model Numbers: 1. 105581 (IDE, cannot be implanted without a Left Ventricular Assist Device (LVAD)) 2. 105581US (cannot be implanted without a LVAD) 3. 105581INT (cannot be implanted without a LVAD) 4. 106524 (IDE) 5. 106524US 6. 106524INT UDI-DI codes: HeartMate 3 LVAS: 1. N/A (IDE) 2. 00813024013266 3. 00813024011675 4. N/A (IDE) 5. 00813024013297 6. 00813024011712 Serial Numbers: For Model 106524 US MLP-000991 MLP-002058 MLP-002066 MLP-002069 MLP-002070 MLP-002076 MLP-002117 MLP-002126 MLP-002128 MLP-002133 MLP-002136 MLP-002152 MLP-002158 MLP-002159 MLP-002160 MLP-002164 MLP-002165 MLP-002191 MLP-002192 MLP-002197 MLP-002206 MLP-002208 MLP-002216 MLP-002217 MLP-002239 MLP-002241 MLP-002246 MLP-002251 MLP-002254 MLP-002259 MLP-002263 MLP-002268 MLP-002269 MLP-002278 MLP-002288 MLP-002289 MLP-002291 MLP-002294 MLP-002300 MLP-002304 MLP-002309 MLP-002310 MLP-002316 MLP-002318 MLP-002321 MLP-002324 MLP-002337 MLP-002342 MLP-002347 MLP-002355 MLP-00

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1301-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.