Saturday, July 13, 2024

Implantable Pulse Generator Recall: Inspire IV IPG Faces Serious Manufacturing Defect

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Inspire Medical Systems, Inc. has announced a significant recall for the Inspire IV Implantable Pulse Generator (IPG) due to a serious manufacturing defect that poses risks of severe injury or death. This recall necessitates the removal of specific devices from use or sale. The U.S. Food and Drug Administration (FDA) has classified this as the most critical type of recall, highlighting the potential danger. The specific product affected is the Inspire IV IPG, with detailed lot and serial numbers provided in the comprehensive recall notice.

In response to this defect, Inspire Medical Systems, Inc. has issued an URGENT Medical Device Correction to all impacted customers. The company has outlined several recommended actions for both healthcare providers and patients to mitigate risks and ensure safety. Healthcare providers are urged to inform their patients about the recall, arrange for appointments to evaluate the functionality of the Inspire therapy, and perform regular check-ups and tests. These non-invasive tests are crucial as they can detect any issues with the device without the need for surgery.

Patients Urged to Seek Immediate Medical Evaluation for Potential Generator Defects

Patients who have been affected by this recall are advised to promptly contact their healthcare providers to schedule routine office visits if they have not been preemptively contacted. During these appointments, non-invasive diagnostic monitoring can help identify any potential defects in the Implantable Pulse Generator. If patients notice new or recurring symptoms such as fatigue, sleepiness, or snoring, they should seek a thorough evaluation from their sleep physician, which might include polysomnography. In cases where revision surgery is necessary to replace the Implantable Pulse Generator, patients can reach out to Inspire’s Patient and Physician Services for more detailed information and guidance.

The recall was initiated because of a manufacturing defect found in the Inspire IV Implantable Pulse Generator Model 3028, which can lead to system malfunctions after implantation. This defect causes electrical leakage in the sensing circuit, potentially requiring revision surgery to replace the Implantable Pulse Generator and restore proper therapy. The use of a defective product can lead to serious adverse health outcomes, such as stimulation below normal therapeutic levels, premature battery depletion, inconsistent stimulation effects, painful stimulation, and even death. To date, there have been no reported injuries or deaths attributed to this defect.


Importance of Implantable Pulse Generator and Critical Recall Actions for Patient Safety

The Implantable Pulse Generator is a vital component of the Inspire Upper Airway Stimulation (UAS) system. This system delivers mild electrical stimulation to the hypoglossal nerve, helping to keep the airway open during sleep. The IPG stores therapy settings configured by a physician and operates with external programmers, which allow the physician to adjust therapy parameters and enable the patient to control the activation and intensity of the therapy. This integration is crucial for maintaining the effectiveness and safety of the therapy for patients with obstructive sleep apnea.

Given the severity of the situation, all affected customers must take the necessary actions outlined in the recall notice. This includes staying in close contact with healthcare providers and adhering to the recommended monitoring and diagnostic procedures to ensure patient safety and device functionality.


Resource: Food and Drug Administration, July 08, 2024

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