A product issue could lead to serious health consequences, including loss of consciousness, bleeding, fluid buildup around the heart and death.
After prompting from the agency, Allergan issued a worldwide recall of its BIOCELL textured breast implants and tissue expanders.
A product malfunction could cause potential over-infusion or unintended delivery of medication.
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.