IPV Therapy Device Recall: Phasitron 5 Breathing Circuits Withdrawn

Percussionaire has issued a Class I recall for certain lots of its Phasitron 5 breathing circuits, crucial components in intrapulmonary percussive ventilation (IPV) therapy, which aids breathing and keeps airways clear for patients on mechanical ventilation. The US Food and Drug Administration (FDA) marked this as a Class I recall, warning of a serious risk if affected devices are still in use.

The recall covers parts P5-10 (lots 240329, 240412, 240430, 240509, 240516, 240614, 240625), P5-HC-5 (lot 240321) and P5-UC-10 (lot 240627).

Following reports of fluid discoloration in the circuits during extended IPV therapy, Percussionaire investigated and identified the issue: an unintended nickel coating on a spring component is reacting with saline mixed with medications such as albuterol or N-acetylcysteine in the nebulizer cup. This reaction not only causes discoloration but also releases nickel particles into the air, potentially exposing patients to elevated nickel levels during use.

High levels of nickel exposure can trigger serious health issues, including lung inflammation, bronchospasm (severe airway narrowing), reduced immunity, allergic reactions and, in rare cases, death. The IPV therapy device recall follows reports of discolored fluid in the breathing circuits and involves a substantial quantity — over 43,800 devices distributed across the US. So far, three cases of adverse reactions have been reported, though no deaths.

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On October 3, 2024, Percussionaire notified customers, instructing them to immediately halt use of any open or used circuits and return all unopened devices. If short-term use of the affected devices is unavoidable, Percussionaire recommends following strict precautions: rinse each circuit with sterile water, air dry, use only saline in the nebulization cup and stop using the device if any symptoms arise. Additionally, devices should not be used to deliver medications, on patients with known nickel allergies or inflammatory conditions or for more than 14 days under these restricted conditions.

The IPV therapy device recall summary pointed to process control issues as the root cause, emphasizing the importance of strict manufacturing standards to prevent similar risks. Percussionaire has committed to replacing affected devices with new, unaffected units.

Percussionaire has also asked all customers to complete and send back a confirmation form by October 18, 2024, to confirm receipt of the recall instructions and their commitment to following the outlined steps.