Agency classClass IOur severity:Critical FDA (Devices)·Z-1227-2014·Announced 2014-04-02

Thoratec HeartMate II Implant Kit Recalled Due to Controller Switching Injuries

Thoratec is recalling HeartMate II Implant Kits because serious injuries and deaths occurred when patients switched from primary to backup System 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 'serious injuries and deaths' were discovered, which meets the rubric criteria for a score of 5 (Critical) due to known fatalities.

Plain-English summary

Thoratec Corporation is recalling HeartMate II Implant Kits with Pocket Controllers, including versions with sealed grafts for North America and the EU. The recall covers 1,737 units of catalog number 106015 and 609 units of catalog number 106016, all serial numbers.

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 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 affected products were distributed worldwide, including nationwide in the United States and in specific countries in Europe, the Middle East, and Asia. Patients and healthcare providers should contact Thoratec Corporation for instructions on how to proceed regarding the use of the device and controller switching procedures.

The recalled product

Product: HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) 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 / Ventricular Assist Device
Hazard: serious-injury
death

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 106015 (NAm) 106016 - 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 →

Same manufacturer · Thoratec Corporation

See all →

Severe
St. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update
FDA (Devices) · 2017-05-31
Severe
St. Jude Medical HeartMate II LVAS Pocket Controller Software and Hardware Update
FDA (Devices) · 2017-05-31
Severe
St. Jude Medical HeartMate II LVAS Software and Hardware Update Recall
FDA (Devices) · 2017-05-31
Critical
Thoratec HeartMate II Pocket Controllers Recalled Due to Reported Deaths
FDA (Devices) · 2014-04-02
Critical
Thoratec HeartMate II System Controller Recalled Due to Injury and Death Reports
FDA (Devices) · 2014-04-02

Same hazard · serious injury