Thoratec Heartmate 3 Sealed Outflow Graft Recall for Leak Risk
Thoratec Corp. is recalling 149 Heartmate 3 Sealed Outflow Graft units because the C-Ring may not seat properly, causing leaks during implantation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (LVAD component) where the device becomes nonfunctional during implantation, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Thoratec Corp. is recalling 149 units of the Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile (REF 105581US/105581). This medical device is a component of the Left Ventricular Assist Device (LVAD) system. The recall affects units with batch/lot numbers 6613000 and below or 50000000 and higher, which have a shelf life of 60 months from the date of manufacture.
The recall is being issued because the outflow graft may leak at the pump connection during the implantation process. This occurs if the C-Ring is insufficiently seated, which renders the device nonfunctional during the surgical procedure. The agency has classified this as a Class II recall.
The affected units were distributed worldwide, including in the United States, Australia, Austria, Brazil, Canada, Cayman Islands, Chile, Colombia, Egypt, France, Germany, Greece, Singapore, Iran, Italy, Kuwait, Lebanon, Romania, Switzerland, Thailand, and the United Kingdom. Healthcare providers and patients should contact Thoratec Corp. for further instructions regarding the replacement or return of these specific units.
The recalled product
- 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
- Manufacturer
- Thoratec Corp.
- Hazard
- Affected units
- 149
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Thoratec Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Thoratec Corp.
See all →- SevereThoratec HeartMate System Monitor display malfunction in left ventricular assist devices
FDA (Devices) · 2024-06-19
- CriticalLeft ventricular assist system implant kit recalled for potential inflow cannula seal leak
FDA (Devices) · 2024-05-08
- SevereThoratec HeartMate 3 Left Ventricle Assist System Recalled for Seal Leak
FDA (Devices) · 2024-05-08
- SevereFDA Recalls HeartMate II Left Ventricular Assist Systems for Graft Obstruction
FDA (Devices) · 2024-03-27
- SevereHeartMate 3 Left Ventricular Assist System recalled for outflow graft obstruction
FDA (Devices) · 2024-03-27
Same hazard · leak
See all →- HighAVID Medical Recalls Halyard LAVH PACK Due to Sterilization Error
FDA (Devices) · 2026-08-26
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- HighAnti-siphon smallbore extension sets recalled over port weld separation risk
FDA (Devices) · 2025-11-05