Medtronic Xomed, Inc. NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Brand
Medtronic Xomed, Inc.
Lot Codes / Batch Numbers
Model Number: NIM4CPB1, UDI/DI: 00763000002985, lot numbers: P1910256, P1910260, P1910402, P1910404, P2008073, P2008130, P2008131 and 00763000395902, lot numbers: P2026275, P2026290, P2026329, P2026330, P2026357, P2026388, P2026389, P2026680, P2026681, P2026718, P2026719, P2026793, P2026956, P2026957, P2026958, P2026959, P2026981, P2026994, P2026995, P2127005, P2127006, P2127013
Products Sold
Model Number: NIM4CPB1; UDI/DI: 00763000002985, lot numbers: P1910256, P1910260, P1910402, P1910404, P2008073, P2008130, P2008131 and 00763000395902, lot numbers: P2026275, P2026290, P2026329, P2026330, P2026357, P2026388, P2026389, P2026680, P2026681, P2026718, P2026719, P2026793, P2026956, P2026957, P2026958, P2026959, P2026981, P2026994, P2026995, P2127005, P2127006, P2127013
Medtronic Xomed, Inc. is recalling NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 due to Software anomaly was identified.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software anomaly was identified.
Recommended Action
Per FDA guidance
The firm issued a recall notification to consignees on 05/03/2022 via mail. The letter instructs the consignee to follow the IFU regarding the setup and "Lead Off Detected" error message, forward the notification to those who need to be aware within the organization and to any location which the devices have been distributed, and to complete the response form. An additional correction notification was sent on about 09/13/2023 to notify consignees of the update availability (NIM Vital" SW version v1.4.3) to fix this issue.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026