Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioni...
FDA Device Recall #Z-1420-2022 — Class II — June 3, 2022
Recall Summary
| Recall Number | Z-1420-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 3, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ambu Inc. |
| Location | Columbia, MD |
| Product Type | Devices |
| Quantity | 12,921 |
Product Description
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
Reason for Recall
Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation of patient.
Distribution Pattern
Domestic distribution nationwide. Foreign distribution to Austria, Belgium, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norge, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, UK Canada, Australia, New Zealand, Israel .
Lot / Code Information
Catalog No: 412351000 UDI-DI: 5707480145706 1 each 5707480145713 5 pc/pack Catalog No. 412371000 UDI-DI: 5707480145737 1 each 5707480145744 5 pc/pack Catalog No. 412391000 UDI-DI: 5707480145768 1 each 5707480145775 5 pc/pack Catalog No. 412411000 UDI-DI: 5707480145799 1 each 5707480145805 5 pc/pack All lots
Other Recalls from Ambu Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2181-2025 | Class I | Ambu SPUR II Labeled as the following: 1 SPUR I... | Jul 9, 2025 |
| Z-1723-2025 | Class II | Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. ... | Apr 7, 2025 |
| Z-0261-2025 | Class II | Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR... | Sep 16, 2024 |
| Z-0714-2024 | Class II | Ambu aView 2 A Monitor, Catalog numbers 4050110... | Dec 5, 2023 |
| Z-2628-2023 | Class II | Ambu aView 2 A Monitor-The Ambu aView 2 Advance... | Jul 21, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.