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Recall of Inspire IV Implantable Pulse Generator Due to Defect

nspire Medical Systems, Inc. has initiated a recall for the Inspire IV Implantable Pulse Generator (IPG), specifically model 3028, after identifying a manufacturing defect that may cause system malfunctions, including electrical leakage in the sensing circuit. This defect could necessitate revision surgery to replace the IPG and restore therapy. The U.S. Food and Drug Administration (FDA) has classified this recall as Class I, indicating the risk of serious injury or death.

Details of the Affected Product:

  • Product Name: Inspire IV Implantable Pulse Generator (IPG)
  • Unique Device Identifier (UDI)/Model: UDI/DI 0855728005915/Model 3028
  • Lot/Serial Numbers: The recall affects thirty-two devices of Model 3028 IPG. A full list of affected serial numbers is available for reference.

Advised Actions for Healthcare Providers and Patients: On June 17, 2024, Inspire Medical Inc. sent an urgent notification to all customers recommending:

  • Healthcare Providers should inform affected patients about the recall, schedule appointments for device checks, and continue regular monitoring.
  • Patients are urged to contact their healthcare providers to ensure their next routine visit is scheduled, attend diagnostic monitoring appointments, and report any new or recurring symptoms to their sleep physician.

Potential Risks: The use of the affected IPGs may result in stimulation below therapeutic levels, battery depletion, inconsistent stimulation effects, painful sensations, or even a perceived shocking sensation. No injuries or deaths have been reported to date.

Device Usage: The IPG is a component of the Inspire Upper Airway Stimulation system, used to maintain airway patency during sleep by delivering mild electrical stimulation to the hypoglossal nerve.

Contact Information: Patients and healthcare providers in the U.S. can contact Inspire Medical Systems at 763-205-7970 or 1-844-OSA-HELP [1-844-672-4357] for more information regarding the recall and next steps.

Additional Resources: The FDA’s Enforcement Report and the Medical Device Recall Database provide further details on this recall. Individuals are also encouraged to report any adverse reactions or quality problems to the FDA’s MedWatch program.

This recall underscores the critical importance of the Unique Device Identifier system in tracking and managing medical devices throughout their distribution and use.

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