Thoratec HeartMate 3 LVAS Implant Kit Recalled for Outflow Graft Leaks
Thoratec Corp. is recalling HeartMate 3 LVAS Implant Kits because an insufficiently seated C-Ring can cause the outflow graft to leak during implantation, rendering the device nonfunctional.
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 involves a high-risk medical device where a defect renders the device nonfunctional during a critical procedure, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Thoratec Corp. is recalling 7,200 units of the HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US. This recall affects Left Ventricular Assist Systems with batch/lot numbers 6613000 or 50000000 or higher. The products were distributed worldwide, including in the United States, Australia, Austria, Brazil, Canada, and other listed countries.
The recall is due to a defect where the C-Ring may be insufficiently seated. If this occurs, the outflow graft connection will leak during the implant procedure, which renders the device nonfunctional. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Healthcare providers and patients should contact Thoratec Corp. for instructions on how to proceed with the recall. The shelf life for these units is 36 months from the date of manufacture.
The recalled product
- Product
- Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
- Manufacturer
- Thoratec Corp.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 7,200
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
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- CriticalLeft ventricular assist system implant kit recalled for potential inflow cannula seal leak
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- SevereThoratec HeartMate 3 Left Ventricle Assist System Recalled for Seal Leak
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- SevereHeartMate 3 Left Ventricular Assist System recalled for outflow graft obstruction
FDA (Devices) · 2024-03-27
- SevereFDA Recalls HeartMate II Left Ventricular Assist Systems for Graft Obstruction
FDA (Devices) · 2024-03-27
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