FDA Device recall Z-2349-2019
Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (…
- FDA Device
- Class II
- terminated
- Published 2019-08-28
On 2019-08-28 the FDA classified a Class II recall of Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (… 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-2349-2019 |
| 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 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
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 | 105581/105581US: The shelf life is 60 months from date of manufacture. All batch/lot numbers 6613000 and below or 5000…105581/105581US: The shelf life is 60 months from date of manufacture. All batch/lot numbers 6613000 and below or 50000000 and higher. UDI/GMDN 00813024013266 / 61747 |
|---|
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-2349-2019%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.