International Life Sciences Recalls Artelon FLEXBAND TWIST Augmentation Devices for Endotoxin Test F
Augmentation devices failed bacterial endotoxin testing.
325 recalls tagged with “electronic”.
Augmentation devices failed bacterial endotoxin testing.
Augmentation devices failed bacterial endotoxin testing.

There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
Potential for rubber fragment detachment during use.
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
Reports of devices sparking/popping and potentially burning patients.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Potential adulteration with erucic acid from mustard oil ingredient.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).