Thoratec HeartMate 3 Left Ventricle Assist System Recalled for Seal Leak
Thoratec recalls HeartMate 3 left ventricle assist systems due to potential leaks at the seal interface. The FDA Class I recall affects 659 implanted devices worldwide.
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: This is an FDA Class I recall of a critical cardiac implant device. Per the severity rubric, FDA Class I recalls require a minimum score of 4. No patient adverse events or injuries have been reported in the source material.
Plain-English summary
Thoratec Corporation is recalling the HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit, a cardiac device designed to mechanically support failing hearts in eligible patients.
The recall addresses a potential leak path that could develop at the seal interface between the inflow cannula and the titanium apical cuff. No patient adverse events have been reported, but a leak at this seal could potentially affect device function.
The recall involves 659 implanted units distributed worldwide, including across all U.S. states and numerous international countries. Affected units are identified by UDI 00813024011712 and specific serial numbers.
Patients with implanted HeartMate 3 devices should contact their healthcare provider or Thoratec Corporation immediately for guidance. Healthcare providers have been notified and should follow Thoratec's instructions regarding device management.
The recalled product
- Product
- Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
- Manufacturer
- Thoratec Corp.
- Hazard
- seal-leak
- device-malfunction
Distribution
Distributed nationwide across the United States.
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