Twin Tubes and BioZorb Markers Get Recalls Designated Class I

Hologic BioZorb Markers with excessive adverse event reports and Vyaire Medical’s Twin Tube with the potential for the nozzle separating during patient use have been deemed as Class I recalls by the FDA.

Hologic is recalling the BioZorb Marker due to complications and adverse events reported with the implanted devices. Complaints included reports of pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device, the FDA said. There have been 71 reported injuries and no reports of death.

The Twin Tube made by Vyaire Medical is being recalled due to the potential for the nozzle to separate during patient use. The separated component may fall into the patient’s mouth resulting in a choking hazard which may lead to an airway obstruction, requiring medical intervention to prevent further injury or harm, the FDA said. There have been no reports of injuries or deaths associated with this issue.

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