Inspire Medical Systems Issues Recall
Inspire Medical Systems has initiated a recall affecting 32 of its Inspire IV implantable pulse generators used for obstructive sleep apnea treatment due to a manufacturing defect. This defect may lead to system malfunctions, including electrical leakage, potentially resulting in serious health issues and the need for revision surgery. The FDA has classified this recall as the most serious type.
Inspire Medical Systems is addressing a manufacturing defect in 32 Inspire IV implantable pulse generators through a field corrective action. This defect can cause electrical malfunctions, posing serious health risks. Affected patients should contact their healthcare providers for routine check-ups and potential revision surgery, while providers need to notify patients and closely monitor the devices. The FDA has identified this recall as the most severe type.
Inspire Medical Systems is recalling its Inspire IV implantable pulse generator model 3028, an essential component of the Inspire upper airway stimulation system for obstructive sleep apnea, due to a manufacturing flaw. This recall involves corrective measures such as informing patients and healthcare providers and conducting additional monitoring. An Inspire Medical spokesperson emphasized that the primary goal is to ensure patient safety without requiring device removal or revision unless absolutely necessary, thereby managing risks while minimizing unnecessary procedures.
The defect can cause system malfunctions post-implantation, leading to electrical leakage in the sensing circuit. Consequently, patients may require revision surgery to replace the pulse generator and restore therapy. The FDA’s recall notice warns that the defect may lead to severe health consequences, including below-normal therapeutic stimulation levels, early battery depletion, inconsistent or inappropriate stimulation effects, painful stimulation, perceived shocking sensations, and even death.
“Patient safety has always been, and continues to be, of paramount importance to Inspire. To that end, we have issued a voluntary field corrective action for all 24 potentially impacted units,” stated Phil Ebeling, chief operating officer at Inspire Medical. According to Ebeling, 24 patients have been notified as part of this action, with eight managed medically, totaling 32 impacted patients. There have been no reported injuries or deaths, according to the FDA’s notice.
Ebeling noted that Inspire Medical has notified regulatory authorities, including the FDA, and sent a letter to affected healthcare providers with specific instructions, including notifying patients of the recall and requesting them to visit the clinic for device testing. “We have also advised healthcare providers to continue monitoring their patients to ensure the devices operate properly and consistently throughout the therapy course,” said Ebeling.
The implantable pulse generator stores therapy settings configured by a physician and delivers mild electrical stimulation to the hypoglossal nerve, which controls tongue muscles to maintain airway patency during sleep. It works with external programmers that allow the physician to set and adjust therapy parameters and the patient to control therapy activation and intensity.
The recall advises regular check-ups and tests to analyze signals and resistance at each visit. According to the Inspire spokesperson, these simple tests can identify device issues without requiring surgery. The FDA has classified this recall as a Class 1 recall, indicating that the device may cause serious injury or death.
Affected Product
Product Name: Inspire IV Implantable Pulse Generator
Unique Device Identifier/Model: 0855728005915/Model 3028
Lot/Serial Numbers: Includes 32 devices of model 3028 implantable pulse generator. See the full list of affected devices.
Actions to Take
Healthcare Providers:
Notify affected patients of this voluntary recall.
Schedule appointments for patients to check if their Inspire therapy is working properly by analyzing signals and resistance. Monitor for any changes in stimulation, therapy effectiveness, or issues with therapy activation.
Continue regular check-ups and tests to analyze signals and resistance at each visit, as these tests can spot device issues without needing surgery.
Patients:
Contact your healthcare provider as soon as possible to ensure you have a routine office visit scheduled.
If you have already been contacted by your healthcare provider, follow up as scheduled.
Attend your scheduled office visit. Routine non-invasive diagnostic monitoring identifies this potential implantable pulse generator defect.
If you experience new symptoms or a reoccurrence of symptoms like fatigue, perceived sleepiness, or snoring problems, contact your sleep physician for a comprehensive evaluation, which may include a polysomnography.
If your provider determines that revision surgery is necessary to replace the implantable pulse generator, you may contact Inspire’s Patient and Physician Services at 1-844-OSA-HELP (1-844-672-4357) for further information.
“Please rest assured that we will continue to cooperate fully and follow up, as appropriate, with regulatory authorities, including the FDA, healthcare providers, and all potentially impacted patients,” stated Ebeling. Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Sources:
https://sleepreviewmag.com/sleep-treatments/therapy-devices/neurostimulators/inspire-recalls-key-component-neurostimulator-therapy-osa/
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=207939
