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andorate® Biopsy Valve

GA Health Company Limited · Model GAR021 · UDI-DI 04897106955169

KTI Prescription
10
510(k) clearances
977
Adverse events (8 deaths)
12
Recalls
65
Facilities

Recalls

DateFirmReason
2025-08-06Olympus Corporation of the AmericasPotential for undetected, deformed a-traumatic tips.
2025-04-04Integra LifeSciences Corp. (NeuroSciences)Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
2023-05-16Bryan Medical IncDevices were mislabeled.
2018-10-17Richard Wolf GmbHThere is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally relevant bonding points / cemented areas of the Bronchoscope Tubes may loosen.
2013-01-11Acclarent, 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.
2013-01-11Acclarent, 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.
2013-01-11Acclarent, 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.
2013-01-11Acclarent, 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.
2013-01-11Acclarent, 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.
2013-01-11Acclarent, 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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Data 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.