Mindray Medical ($MR), China's largest medical device company, has launched a voluntary recall of its A3/A5 Anesthesia Delivery System, warning that the devices can leak CO2.
The problem stems from improper seating of a canister gasket in the devices, and while Mindray says it hasn't received any reports of injury, the risk of malfunction was enough to warrant a recall. The company notified its customers of the problem in August and has since repaired about 70% of the units in the field, Mindray says.
The FDA has been made aware of the voluntary recall but is yet to assign it a class. The company is asking customers to report any related adverse events to the FDA through its online MedWatch system.
Mindray has ascended to the top of the Chinese device market of late, largely through a slew of acquisitions. And while the company has continued to expand its North American market share, a disappointing third quarter dulled its progress. Mindray's net income dropped 4.2% in Q3, and Wall Street dealt its shares their biggest slump in a year as a result.
- read Mindray's release