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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Affected units
- 659
Distribution
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.
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