NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 822
FDA device recall Z-0696-2024 · posted 2024-01-10 · Open, Classified
Recall details
- Recalling firm
- Medtronic Xomed, Inc.
- Reason for recall
- Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
- Action taken
- Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/07/2023 via 2-day UPS mailing. The notice explained the problem, the potential health risk, and requested segregation and quarantine pending return of the affected product. For questions, contact: neuro-quality@medtronic.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- ETN
- Quantity affected
- 80569 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2023-11-07
- Date posted
- 2024-01-10
- Location
- Jacksonville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEXT GEN EMG ENDOTRACHEAL TUBE (K112686) | Medtronic Xomed, Inc. | 2012-06-27 |