The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1228-2014·Announced 2014-04-02

Thoratec HeartMate II System Controller Recalled Due to Injury and Death Reports

Thoratec is recalling HeartMate II System Controllers because serious injuries and deaths occurred when patients switched from primary to backup controllers.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly reports 'serious injuries and deaths,' which meets the rubric criterion for a score of 5 (Critical) due to known fatalities.

Plain-English summary

Thoratec Corporation is recalling the HeartMate II System Controller. The HeartMate II is a mechanical device, also known as a ventricular assist device (VAD), that circulates blood throughout the body when the heart is too weak to pump adequately on its own. It is designed to assist or take over the pumping function of the patient's left ventricle.

The recall was initiated due to the discovery of serious injuries and deaths associated with the process of changing from a primary System controller to a back-up System controller in patients using the Pocket System controller model.

The recall affects 4,120 units with catalog numbers 106762 (North America) and 106017 (EU), covering all serial numbers. The devices were distributed worldwide, including nationwide in the United States and in several countries across Europe, the Middle East, and Asia. Patients using the affected devices should contact their healthcare provider or Thoratec Corporation for instructions on how to proceed.

The recalled product

Product
HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD.…
Manufacturer
Thoratec Corporation
Category
Medical Device — Ventricular Assist Device (VAD)
Hazard
Affected units
4,120

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)

  • Catalog number 106762 (NAm) 106017 - EU all serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Thoratec Corporation 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 4 products in this recall →

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