Important Safety Alerts
Medical Device Safety Alert: Medtronic Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators
28 Feb 2018
The United States Food and Drug Administration (FDA) has issued an alert concerning Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs), manufacturer by Medtronic. The affected products are identified as follows:
- Product Codes: NIK, LWS
- Serial Numbers: Refer to the FDA website.
- Manufactured from 13 July 2013 to 8 August 2017.
The manufacturer is recalling certain ICDs and CRT-Ds due to a defect in the manufacturing process. This defect causes an out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient's heartbeat or revive a patient in cardiac arrest.
According to the manufacturer, the delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient's heart whose heartbeat is too slow could result in serious injury and/or death.
The affected customers are asked to take to following actions:
- Consider Prophylactic device replacement for patients who have been implanted with one of the affected devices.
- Contact their Medtronic sales representative for terms and conditions for device warranties.
- Review the recall notice and ensure appropriate staff is aware of the notice.
The manufacturer will offer a supplemental device warranty for affected devices.
For details, please refer to the FDA website:
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm598198.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 28 February 2018