The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1230-2014·Announced 2014-04-02

Thoratec HeartMate II Pocket Controllers Recalled Due to Reported Deaths

Thoratec is recalling HeartMate II Pocket Controllers because serious injuries and deaths were reported 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 states that deaths were reported, which mandates a severity score of 5 (Critical) according to the rubric.

Plain-English summary

Thoratec Corporation is recalling HeartMate II Pocket Controllers that were removed from packaging. The HeartMate II is a mechanical device used to circulate blood throughout the body when the heart is too weak to pump blood adequately on its own.

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.

A total of 7,436 units are affected. These units have catalog number 105109, which is found on the side of the unit, and include all serial numbers. The devices were distributed worldwide, including nationwide in the United States and in various countries across Europe, the Middle East, and Asia.

The recalled product

Product
Heart Mate II Pocket Controllers removed from packaging 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.
Manufacturer
Thoratec Corporation
Category
Medical Device — Cardiovascular
Hazard
Affected units
7,436

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 105109 (found on side of unit) 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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