Thoratec HeartMate 3 Mobile Power Unit Recalled for Static Electricity Risk
Thoratec Corp. is recalling HeartMate 3 Mobile Power Units because excessive static electricity can cause unrecoverable power loss, potentially reducing blood flow from the left ventricular assist system.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a life-support device where power loss could lead to no or reduced blood flow, posing a significant risk of serious injury.
Plain-English summary
Thoratec Corp. is recalling HeartMate 3 Mobile Power Units (REF 107754 and 107758) when connected to the HeartMate 3 Left Ventricular Assist System (REF 106524US and 106524). The recall involves 13,871 units distributed nationwide across 40 states and the District of Columbia. All serial numbers are affected.
The recall is due to a risk that excessive static electricity can cause unrecoverable power loss and damage to the mobile power unit. This failure could lead to no or reduced blood flow from the left ventricular assist system, which is a critical life-support device.
Patients using these devices should contact their healthcare provider or Thoratec Corp. for instructions on how to proceed. The Mobile Power Unit is used for home or clinical use when the patient is indoors, stationary, or sleeping.
The recalled product
- Product
- HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage: P
- Manufacturer
- Thoratec Corp.
- Category
- Medical Device — Cardiovascular
- Affected units
- 13,871
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers.
Distribution
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