Reported Mar 27, 2024 · Ongoing
HeartMate II Left Ventricular Assist System (LVAS)
Thoratec Corp.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Thoratec Corp. · 6035 Stoneridge Dr · Pleasanton, CA · 94588-3270
Is this the product you have?
HeartMate II Left Ventricular Assist System (LVAS)
13 of 13 products
| Model / number | Product as published |
|---|---|
103393 | HeartMate II Sealed Outflow Graft with Bend Relief |
106015 | HeartMate II LVAS Implant Kit, US |
106016 | HeartMate II LVAS Implant Kit, OUS Update (February 14, 2024) HeartMate II Left Ventricular Assist System (LVAS) |
102139 | HeartMate II LVAS Implant Kit, OUS |
1355 | HeartMate II LVAS Implant Kit, US |
103695 | HeartMate II LVAS Implant Kit (with RSOC Controller), US |
103693 | HeartMate II LVAS Implant Kit (with RSOC Controller), OUS |
104911 | HeartMate II LVAS Implant Kit (with Sealed Graft), US |
104912 | HeartMate II LVAS Implant Kit (with Sealed Graft), OUS |
107801 | HeartMate II LVAS Implant Kit (Used for pump exchange, No Graft) |
103695-CAN | HeartMate II LVAS Implant Kit, (EPC), CANADA |
104911JPN | HeartMate II LVAS Implant Kit (with Sealed Graft), JAPAN |
106515OUS | HeartMate II LVAS Implant Kit (with Pocket System Controller and Sealed Grafts), for geographies outside of US & EU HeartMate II Left Ventricular Assist System: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system. One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries. |
- Lot codes and dates
26 of 26 products
Products covered by this recall # Barcodes Product as published 1 103393 (cannot be implanted without a LVAD) 2 106015 (US) 3 106016 (OUS) Update (February 14, 2024) HeartMate II LVAS 4 102139 (OUS), includes Unsealed Outflow Graft with Bend Relief 5 1355 (US), includes Unsealed Outflow Graft with Bend Relief 6 103695 (US), includes Unsealed Outflow Graft with Bend Relief 7 103693 (OUS), includes Unsealed Outflow Graft with Bend Relief 8 104911 (US) 9 104912 (OUS) 10 107801 (US), does not include Outflow Graft 11 103695-CAN, includes Unsealed Outflow Graft with Bend Relief 12 104911JPN 13 106515OUS UDI-DI codes: HeartMate II LVAS 14 0081302401080700813024010807 15 0081302401122400813024011224 16 0081302401123100813024011231 Update (February 14, 2024) HeartMate II LVAS 17 N/A 18 0081302401000500813024010005 19 0081302401061600813024010616 20 0081302401062300813024010623 - Amount recalled
- 2,240 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Thoratec Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.