FDA announces Class 1 recalls for nerve monitoring system, ambulatory infusion pumps

Editor's Note

The US Food and Drug Administration (FDA) designated recalls of Medtronic’s NIM Vital Nerve Monitoring System and Smith Medical’s CADD-Solis Ambulatory Infusion Pumps as Class 1, the most severe category indicating serious risk of injury or death.

Reports of false negative responses prompted Medtronic to recall the nerve monitoring system, which issues an EMG tone during surgery when the probe is placed on nerve, due to risk of nerve damage, weakening, and paralysis. FDA’s August 6 announcement advises users to be aware of false negatives, in which stimulation does not prompt an EMG tone, and to rely on alternate monitoring, surgical skills, experience and anatomical knowledge to prevent damage to nerves if monitoring is compromised. The company is reportedly deploying a software fix to correct the issue, which has resulted in 10 reports of injuries and no deaths.

Also announced August 6, the recall of CADD-Solis Ambulatory infusion Pumps—used for intravenous intra-arterial,  subcutaneous, intraperitoneal, intraoperative, and epidural space or subarachnoid space infusions—was prompted by multiple issues that may occur without the latest software version. These include:

• Failure to alarm when there is an upstream occlusion
• Unresponsive stop and power keys
• Air detector fails to start in manual mode
• Failure to alarm for Single Bubble Air Detection
• System error codes do not display at power up
• No audible alarm sound
• Air in Line Detection threshold may be too high

Such issues present the risk of serious adverse health consequences related to delay, interruption, under- or over-administration of therapy, or death, FDA reports. There has been one reported injury and no reports of death. The manufacturer corrected many of the issues through software updates. Affected products use the following software: CADD-Solis software versions earlier than v.4.2, CADD-Solis VIP software versions earlier than v.1.6, nad PharmGuard server software versions earlier than v.2.6.