The US Food and Drug Administration (FDA) has announced a recall of the Livanova TandemLife LifeSparc System, a medical device used for circulatory support during heart surgery. The recall was initiated due to the potential for the device to experience unintentional extended pump stops, which could result in serious adverse health consequences for patients.
About the LifeSparc System
The LifeSparc System is a device that provides circulatory support to patients undergoing heart surgery. It is designed to work in tandem with the heart, pumping blood and maintaining circulation during surgical procedures. However, the FDA has found that the device may experience unintended extended pump stops, which can result in serious harm to patients.
FDA instructions to providers and patients
The FDA is urging health care providers to immediately stop using the affected devices and to return them to the manufacturer. Livanova TandemLife is working closely with the FDA to ensure a safe and effective recall process.
Patients who have undergone surgery with the LifeSparc System should contact their healthcare provider if they have any concerns or experience any adverse health effects. Health care providers are encouraged to report any adverse events related to the use of the device to the FDA’s MedWatch Adverse Event Reporting program.
The FDA remains committed to ensuring the safety and effectiveness of all medical devices, and is working closely with manufacturers and healthcare providers to address any issues that arise. Patients and health care providers are encouraged to stay informed about the latest developments and to report any concerns or adverse events related to the use of medical devices.
Summary
In conclusion, the FDA has announced a recall of the Livanova TandemLife LifeSparc System due to the potential for the device to experience unintended extended pump stops. Health care providers are urged to stop using the affected devices and to report any adverse events to the FDA. Patients who have undergone surgery with the LifeSparc System should contact their healthcare provider if they have any concerns.
More information
See the FDA announcement for more information about tbe recall.