FDA Device recall Z-2348-2019
Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
- FDA Device
- Class II
- terminated
- Published 2019-08-28
On 2019-08-28 the FDA classified a Class II recall of Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System by Thoratec, citing outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2348-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-30 |
| Published | 2019-08-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Thoratec |
| Distribution | US |
Product
Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
Reason
Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.
Identifiers
| code_info | 106524/106524US: The shelf life is 36 months from date of manufacture. All batch/lot numbers 6613000 or 50000000 or hi…106524/106524US: The shelf life is 36 months from date of manufacture. All batch/lot numbers 6613000 or 50000000 or higher. UDI/GMDN 00813024013297 / 47533 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Thoratec
- Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description…
FDA Device · Class II · 2026-06-24 · Thoratec - Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Pr…
FDA Device · Class II · 2026-06-24 · Thoratec - Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Descriptio…
FDA Device · Class II · 2026-06-24 · Thoratec - CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016
FDA Device · Class II · 2026-01-21 · Thoratec - Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US
FDA Device · Class II · 2025-11-26 · Thoratec
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2348-2019%22
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