Ventricular (assist) Bypass
Unknown
Approved pma: P870072
Recent MDR events
157,431 adverse event reports on file
- Thoratec® HeartMate 3® LVAS Implant KitJul 31, 2026DeathThoratec Corporation2916596-2026-2918743
- HeartMate 3 LVAS Implant KitJul 31, 2026DeathThoratec Corporation2916596-2026-2918845
- THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)Jul 31, 2026MalfunctionThoratec Corporation2916596-2026-2918554
- Thoratec® HeartMate 3¿ System ControllerJul 31, 2026MalfunctionThoratec Corporation2916596-2026-2918918
- Thoratec® HeartMate 3® LVAS Implant KitJul 31, 2026MalfunctionThoratec Corporation2916596-2026-2918446
- THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)Jul 31, 2026InjuryThoratec Corporation2916596-2026-2918655
- Thoratec® HeartMate 3® LVAS Implant KitJul 31, 2026InjuryThoratec Corporation2916596-2026-2918687
- Thoratec® HeartMate 3® LVAS Implant KitJul 31, 2026DeathThoratec Corporation2916596-2026-2918688
- Thoratec® HeartMate 3® LVAS Implant KitJul 31, 2026InjuryThoratec Corporation2916596-2026-2918618
- HeartMate 3 LVAS Implant KitJul 31, 2026DeathThoratec Corporation2916596-2026-2918660
Event type breakdown
Recalls
131 recall events for this product code
- Thoratec LLCOpen, ClassifiedJun 18, 2026
Brand Name: HeartMate
Due to 11 volt Backup Battery failures.
Z-2518-2026 · View FDA record ↗ - Thoratec LLCOpen, ClassifiedJun 18, 2026
Brand Name: HeartMate
Due to 11 volt Backup Battery failures.
Z-2519-2026 · View FDA record ↗ - Thoratec LLCOpen, ClassifiedJun 18, 2026
Brand Name: HeartMate
Due to 11 volt Backup Battery failures.
Z-2520-2026 · View FDA record ↗ - BERLIN HEART GMBHOpen, ClassifiedJun 5, 2026
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Z-2320-2026 · View FDA record ↗ - Thoratec LLCOpen, ClassifiedNov 14, 2025
Brand Name: HeartMate
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Z-0505-2026 · View FDA record ↗ - Thoratec LLCOpen, ClassifiedNov 14, 2025
Brand Name: HeartMate
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Z-0506-2026 · View FDA record ↗ - Thoratec LLCOpen, ClassifiedNov 14, 2025
Brand Name: HeartMate
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Z-0507-2026 · View FDA record ↗ - Thoratec LLCOpen, ClassifiedNov 14, 2025
Brand Name: HeartMate
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
Z-0508-2026 · View FDA record ↗ - Thoratec LLCOpen, ClassifiedAug 13, 2025
Brand Name: HeartMate
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Z-2290-2025 · View FDA record ↗ - Thoratec LLCOpen, ClassifiedAug 13, 2025
Brand Name: HeartMate
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Z-2291-2025 · View FDA record ↗
Registered firms
35 firms currently registered for this product code
Berlin Heart Gmbh
Berlin, DE
Inventus Power
Woodridge, IL, US
Sterigenics Germany Gmbh
Wiesbaden Hesse, DE
Phillips-medisize Costa Mesa Llc
Costa Mesa, CA, US
Thoratec Corp.
PLEASANTON, CA, US
Thoratec Corporation
San Ramon, CA, US
Vascutek Ltd.
Inchinnan Renfrewshire, GB
Sterigenics U.s., Llc
Salt Lake City, UT, US
Greatbatch Medical S. De R.l. De C.v.
Tijuana Baja California, MX
Heartware, Inc.
Miami Lakes, FL, US
Medtronic, Inc.
Mounds View, MN, US
Lynx Medical Pennsylvania
ERIE, PA, US
Lowell,inc.
Brooklyn Park, MN, US
Sterigenics U.s., Llc
Queensbury, NY, US
Berlin Heart, Inc.
The Woodlands, TX, US
Centerpiece S. De R.l De C.v (sterilization Site)
Tijuana Baja California, MX
Thoratec Corp
BURLINGTON, MA, US
Sterigenics U.s., Llc
Corona, CA, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
9 premarket approvals for this product code
- AbbottDec 6, 2019
P170038 · CentriMag Circulatory Support System
- ABBOTT MEDICALAug 23, 2017
P160054 · HeartMate 3 Left Ventricular Assist System
- Berlin Heart, Inc.Jun 6, 2017
P160035 · EXCOR Pediatric Ventricular Assist Device
- MedtronicNov 20, 2012
P100047 · HEARTWARE VENTRICULAR ASSIST SYSTEM
- ABBOTT MEDICALApr 21, 2008
P060040 · THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Worldheart, Inc.Sep 29, 1998
P980012 · NOVACOR LVAS
- Thoratec Laboratories Corp.Dec 20, 1995
P870072 · THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
- Thoratec CorpSep 30, 1994
P920014 · HEARTMATE VE LVAS