AFX Endovascular AAA Systems Recalled by Endologix, Inc. for Risk of Type III Endoleaks

Not sure what’s been recalled, withdrawn from the market, or had safety updates? Catch up on the US Food and Drug Administration’s (FDA)’s recalls and safety news from this past week.

AFX Endovascular AAA Systems Recalled by Endologix, Inc. for Risk of Type III Endoleaks

Due to continued reports of Type IIIa and IIIb endoleaks, Endologix, Inc. is recalling s AFX Endovascular AAA Systems.

Type III endoleaks increase the likelihood of a rupture since they cause blood to continuously flow into the aneurysm.

Serious patient injuries, such as an abdominal aortic aneurysm (AAA) rupture or death, can occur if the endoleaks are left undetected and without treatment.

To view the lots being recalled, check out the US Food and Drug Administration’s (FDA’s) statement.

Zero Xtreme Recalled by Fat Burners Zone for Undeclared Sibutramine

For the presence of undeclared sibutramine, Fat Burners Zone is voluntarily recalling 1 lot of Zero Xtreme capsules to the consumer level.

The recalled dietary supplement was sold in gray aluminum bottles with gray aluminum caps, with 30 capsules in each bottle. The affected Zero Xtreme lot is #1220062085 and expires 03/2020.

Since sibutramine—an appetite suppressant—was withdrawn from the US market due to safety concerns. Its presence in Zero Xtreme makes the product an unapproved drug.

For more information on this recall, check out the FDA’s statement.

Safety Information Updated for LivaNova 3T Heater-Cooler Systems

For potential cardiac surgery infections, LivaNova’s 3T Heater-Cooler Systems were issued a Medical Device Correction letter.

A first safety communication was issued by the FDA in October 2015; the second letter was issued to provide further instructions to healthcare providers.

The 2018 Medical Device Correction letter letter encourages healthcare providers to be aware of the safety update and follow the 3T operating instructions, follow the daily hydrogen peroxide monitoring instructions, and be aware of the 3T design upgrade.

For more information on this safety update, check out the FDA’s statement.