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Richard Wolf GmbH · Model 8214082 · UDI-DI 04055207014394
10
510(k) clearances
977
Adverse events (8 deaths)
12
Recalls
65
Facilities
Description
BRONCHOSCOPE-TUBE ID 8.5MM model Wolf, OD 9.5mm, TL 400mm, with fixed distal light carrier, without distal viewing window, reusable
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-06 | Olympus Corporation of the Americas | Potential for undetected, deformed a-traumatic tips. |
| 2025-04-04 | Integra LifeSciences Corp. (NeuroSciences) | Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton. |
| 2023-05-16 | Bryan Medical Inc | Devices were mislabeled. |
| 2018-10-17 | Richard Wolf GmbH | There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally relevant bonding points / cemented areas of the Bronchoscope Tubes may loosen. |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. |
| 2013-01-11 | Acclarent, Inc. | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps. |
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