Company: Abbott
Date of Enforcement Report: 1/3/2024
Class I
PRODUCT
HeartMate Touch Communication System (version 1.0.32)
Recall Number:
Z-0842-2024
REASON:
Abbott is recalling their HeartMate Touch System (version 1.0.32) for risk of unexpected pump stop or start. Issues may occur if the HeartMate Touch System is disconnected from a patient’s HeartMate Controller while a “pump stop” command is running. When the HeartMate Touch is reconnected to the same or a new controller, depending on the status of the pump at connection the pump will either stop or start. If the pump was stopped at reconnection, the pump will restart. If the pump is running at reconnection, a pump stop will occur. There are no alarms or indications that warn the user that the “pump stop” command is still in the command queue.
The use of the affected system may cause serious adverse health consequences, including lightheadedness, sudden change in blood flow, loss of consciousness, and death.
There have been 8 reported injuries and no reports of death.
RECALLING FIRM/MANUFACTURER:
Abbott
VOLUME OF PRODUCT IN COMMERCE:
1,560 devices distributed in the United States from May 7, 2020 to December 18, 2023.
DISTRIBUTION:
Worldwide distribution. US nationwide, Australia, Austria, Canada, Colombia, Czech Republic, Germany, Hong Kong, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Martinique, New Zealand, Poland, Romania, Saudi Arabia, Singapore, Spain, Switzerland, Thailand and United Arab Emirates
