Medtronic Xomed, Inc.: Device Recall

Recall #Z-2409-2024 · 06/24/2024

Class I: Dangerous

Recall Details

Recall Number: Z-2409-2024
Classification: Class I
Product Type: Device
Recalling Firm: Medtronic Xomed, Inc.
Status: Ongoing
Date Initiated: 06/24/2024
Location: Jacksonville, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7,804 units

Reason for Recall

Potential for false negative response on the NIM Vital Nerve Monitoring System

Product Description

NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number: NIM4CM01RF, 3. PATIENT INTERFACE NIM4CPB1 NIM 4.0, Model Number: NIM4CPB1, 4. PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, Model Number: NIM4CPB1RF, 5. SOFTWARE NIM4SWU143 UPGRADE V1.4.3, Model Number: NIM4SWU143

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic Of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.

Other Recalls by Medtronic Xomed, Inc.

Class II: Risk 07/17/2025

Due to out of the box wobble of the driver.
Class II: Risk 03/10/2025

Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
Class II: Risk 07/05/2024

Product was distributed past expiration date.

View all recalls by Medtronic Xomed, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.