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Insighters
Shenzhen Insighters Medical Technology Co., Ltd. · Model 5Fr · UDI-DI 06970831723369
1
510(k) clearances
1,573
Adverse events (12 deaths)
10
Recalls
36
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-16 | Ambu Inc. | Ambu has received complaints on Ambu VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intub |
| 2022-06-03 | Ambu Inc. | 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 r |
| 2019-10-30 | Teleflex Medical | The tracheal and brochial swivel connectors are incorrectly labeled. |
| 2016-12-16 | Parker Medical | The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended. |
| 2015-06-01 | Teleflex Medical | The double swivel connector may crack or separate on the endobronchial tube. |
| 2015-06-01 | Teleflex Medical | The double swivel connector may crack or separate on the endobronchial tube. |
| 2015-06-01 | Teleflex Medical | The double swivel connector may crack or separate on the endobronchial tube. |
| 2015-06-01 | Teleflex Medical | The double swivel connector may crack or separate on the endobronchial tube. |
| 2005-02-23 | Teleflex Medical | The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and catalog number 5-161 |
| 2005-02-23 | Teleflex Medical | The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and catalog number 5-161 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.