The agency is recommending that patients replace their affected pumps with models that can better protect against the risks.
The Class I recall involves complaints that the connector disconnects from the breathing unit.
Using automated technologies can help medtech manufacturers de-risk their supply chain, increase productivity and save costs.
Risks related to balloon deflation, fragmentation and detachment could lead to serious adverse events, including death.
There have been reports of Type llla and lllb endoleaks related to the company’s AFX Endovascular AAA Systems.
There is a risk that the delivery wire could break or separate during use, being left inside the patient’s bloodstream as a result.
In the United States, the company has recalled nearly 360,000 AirLife Resuscitation Device and Broselow Convenience Kits due to a malfunction risk.
The issue causes interference in the accuracy of the test method.
The company’s ED-3490TK duodenoscopes require replacement of the forceps elevator mechanism and other parts.
A manufacturing error could cause chamber parts to split into layers and cause water to back up into the patient breathing circuit.