Agency classClass IIOur severity:High FDA (Devices)·Z-2952-2024·Announced 2024-09-11

Desflurane anesthesia vaporizer recalled for possible excessive anesthetic output

Mindray's Desflurane E_Vap vaporizer may deliver anesthetic at higher concentrations than set due to an incomplete seal. Patients could inhale excessive anesthetic, potentially causing dizziness, drowsiness, and in severe cases, neurological effects.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II medical device recall involving potential anesthetic vaporizer malfunction that could result in excessive anesthetic exposure. No illnesses or injuries have been reported, making this a theoretical risk-of-harm situation.

Plain-English summary

The Desflurane E_Vap (Saf-T-Fill) vaporizer, used with the Mindray A9 Anesthesia System, is being recalled due to a potential safety defect. A component within the vaporizer may cause an incomplete seal in some cases, resulting in anesthetic agent output that exceeds the set amount.

When this defect occurs, the A9 Anesthesia System generates alarms to alert clinicians to the abnormal vaporizer output. If the anesthetic concentration becomes too high, patients may inhale excessive amounts of anesthetic agent. This can cause symptoms such as vertigo and drowsiness after the procedure. In severe cases, patients may experience neurological effects including memory impairment and inattention.

The recall affects 96 units distributed in the United States to California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia, and to Canada internationally.

Healthcare facilities that have received affected units should verify their serial numbers against the recall notice and contact Mindray North America for information about device replacement or remedial measures.

The recalled product

Product: Desflurane E_Vap.(Saf-T-Fill) 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: Part Number115-066759-00
Manufacturer: Mindray DS USA, Inc. dba Mindray North America
Category: Medical Device — Anesthesia Equipment
Hazard: anesthetic-overdose
neurological-effects
Affected units: 96

Distribution

Distributed in 8 states:

Part of a larger recall action

This product is one of 4 recalled by Mindray DS USA, Inc. dba Mindray North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Mindray DS USA, Inc. dba Mindray North America

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Same hazard · anesthetic overdose