Anesthesia Vaporizer Adapter May Deliver Excessive Anesthetic Concentration
Sevoflurane vaporizer adapters used with Mindray A9 anesthesia systems may deliver higher-than-set anesthetic concentrations due to incomplete sealing. Patients could inhale excessive anesthetic, potentially causing drowsiness, vertigo, or in severe cases, neurological effects.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall without reported illnesses or injuries. The hazard—excessive anesthetic exposure—is a risk of harm that could cause neurological effects, but no confirmed harm has been reported. Per the rubric, such risk-of-harm products where injury has not yet been reported score at 3 (High).
Plain-English summary
Mindray is recalling Sevoflurane E_Vap safety filling adapters (Part Number 115-066756-00) used with the A9 Anesthesia System. In some units, a component within the vaporizer may not seal completely, causing the system to deliver anesthetic vapor at concentrations higher than the set amount.
When anesthetic concentration exceeds the intended level, patients may inhale excessive anesthetic agent. The A9 system is designed to generate alarms indicating abnormal vaporizer output, but the high concentration could still be delivered to the patient.
The recall affects 96 units distributed to surgical facilities in California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, West Virginia, and Canada. Patients who received anesthesia with affected adapters may experience drowsiness, vertigo, or other symptoms after surgery. In severe cases, neurological effects such as memory loss or difficulty concentrating may occur. Healthcare providers should discontinue use of affected adapters and contact Mindray for guidance on replacements or corrective actions.
The recalled product
- Product
- Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: 115-066756-00
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Hazard
- anesthetic-overdose
- neurological-effects
- vertigo
Distribution
Distribution scope not specified by the agency.
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