A Drug & Medical Device Recall And/Or Safety Alert Has Been Issued: Acclarent Inspira AIR Balloon Dilation System: Class 1 Recall – Potential For Balloon To Not Deflate Or To Deflate To Slowly. According to the Food & Drug Administration FDA’s MedWatch:
Prolonged obstruction of the airway may prevent adequate blood oxygenation, which could cause temporary or permanent impairment to the patient
For more information on the drug or medical device recall or safety alert, read the Food & Drug Administration’s FDA’s drug or medical device recall or safety alert: Acclarent Inspira AIR Balloon Dilation System: Class 1 Recall – Potential For Balloon To Not Deflate Or To Deflate To Slowly.
To report an adverse reaction, problem or other issue with a drug or medical device, submit a drug or medical device complaint to the government at fda.gov or MedWatch.
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