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The Phasitron 5 IPV medical device breathing circuits used in intrapulmonary percussive ventilation (IPV) therapy were recently recalled due to a design flaw in their nickel coating. The elevated levels of nickel exposure can severely impact patient safety.
We are no longer accepting Phasitron 5 Intrapulmonary Percussive Ventilation (IPV) cases.
On November 1, 2024, the U.S. Food & Drug Administration (FDA) issued an alert that Percussionaire was voluntarily recalling 43,630 units of its Phasitron 5 breathing circuits. The federal agency classified the recall as its most serious type of recall.
The medical device recall stemmed from the unexpected discovery of a nickel coating on one part of the circuit. This coating can react with certain saline solutions mixed with albuterol or N-acetylcysteine. When this happens, it can cause discoloration and may release nickel particles into the air. This could expose patients to higher nickel levels than expected during regular use.
In response, Percussionaire issued a recall for affected units, recognizing that continued use could cause life-threatening complications. The recalled part lot numbers include:
The FDA has instructed medical facilities and patients to stop using the recalled units immediately to avoid potentially catastrophic outcomes. However, in the event of an emergency, Percussionaire and the FDA issued the following updated safety instructions:
According to Percussionaire, it has notified customers of the recall and presented information on how to obtain replacements for their medical devices.
The Phasitron 5 ILV device may cause serious injury. The failure of the Phasitron 5 In-Line Valve can result in a variety of adverse events, including:
As of November 2024, three injuries have been reported to the FDA Medical Device Recall Database. To date, no deaths have been reported in connection with the impacted products. However, the serious risks to patient health prompted the FDA to give the recall its Class I designation.
If you have reason to believe your Phasitron is affected by nickel exposure, take the following steps:
Victims impacted by the defective Phasitron 5 breathing circuits may be eligible for financial compensation covering:
Your Phasitron 5 settlement or verdict will depend on the type and severity of your injuries. Our Phasitron lawyers will calculate your damages and work to get you the compensation you deserve.
Levin Law