By Sree Roy
Sleep professionals are understandably anxious about product recall notices in the wake of the long-lasting negative impacts of the CPAP recall by Philips Respironics. But I predict that the recent recall of Inspire IV implantable pulse generators will ultimately be much less anxiety-stoking for patients and sleep physicians. I’m basing my expectations on a conversation I had with executives from Inspire Medical to clarify the recall details.
Inspire IV Recall by the Numbers
Inspire’s Class 1 recall, announced earlier this summer, is for 32 Inspire IV implantable pulse generators (model 3028). Inspire IV is the latest generation of the company’s devices, approved for the treatment of obstructive sleep apnea by the US Food and Drug Administration (FDA) in 2017. The 32 impacted patients were implanted between August 2022 and May 2023.
The recall is drastically more limited in scope than the Philips recall. It is limited to 32 patients, according to Inspire executives. Specifically, it encompasses:
- 32 patients globally (total)
- Eight (so far) have had the implantable pulse generator replaced with a different one
- 24 patients still have one of these implantable pulse generators inside them (21 in the United States; three in Germany)
- The 21 serial numbers for the US devices still in use are: AIR324492C, AIR324493C, AIR324494C, AIR324496C, AIR324500C, AIR324502C, AIR324503C, AIR324504C, AIR324506C, AIR324507C, AIR324508C, AIR324509C, AIR324510C, AIR324511C, AIR324515C, AIR324517C, AIR324518C, AIR324520C, AIR324521C, AIR324522C, AIR324523C
Steps for Impacted Patient/Physician Teams
Unlike the Philips recall, the devices do not immediately need to be replaced—though patients will incur no out-of-pocket costs if they opt for revision surgery, according to Inspire.
Since all the recalled devices have been implanted, there are no outstanding pulse generators to be returned to Inspire. That also means any implantable pulse generators in the field that have not been implanted are not in the recalled lot.
The 21 impacted US patients need an in-person sleep physician appointment to check their Inspire therapy’s signals and resistance. Sleep physicians must monitor for changes in the stimulation, lack of therapy effectiveness, or problems with turning on the device.
“We’re not asking people to immediately have a surgery to replace the device,” says Phil Ebeling, Chief Operating Officer at Inspire Medical. “There will be some patients who say, ‘Even if I’m not having trouble with it, I want it replaced.’ That’s up to the discretion of the physician, and we will support that. Other people will say, ‘I’ll deal with [revision surgery] if I have to. I’ll take my chances.’ The physician and patient together can make the best choice for them.”
Testing Signals and Resistance
For these 21 patients, sleep physicians must conduct regular check-ups and tests to analyze signals and resistance, as these tests can spot issues caused by the manufacturing defect.
The potential issues include system malfunctions leading to electrical leakage in the sensing circuit, which may cause stimulation below normal therapeutic levels, early battery depletion, painful stimulation, and death. According to the FDA, there have been no reported injuries or deaths. “The problem itself may or may not occur. It’s variable,” Ebeling says.
Testing the Inspire IV pulse generator’s signals and resistance takes about four minutes, and the results are provided right away. “The physician programmer interrogates the device. It’s an in-office, noninvasive measurement,” Ebeling says. “We collect impendence measurements and waveform readings and make sure everything is working as intended.”
Patients will incur no extra costs for these tests, Inspire says. “No one will pay for this other than insurance and us,” Ebeling says.
Identifying the Inspire IV Defective Lot
During its post-market surveillance, the data mining team at Inspire Medical noticed unusual complaint patterns linked to a specific lot of pulse generators. “We looked at the frequency of complaints and the type of complaint relative to this manufacturing lot. We connected the dots and said, ‘OK, something is wrong here,’” Ebeling says.
For this particular lot, a check of the manufacturer’s records revealed a human error—a specific operator did not meet the device’s manufacturing specifications. “Everything before and after was to spec,” Ebeling says. “We are confident that we’ve bounded it right, and it’s limited to this particular lot. But we’re going to continue to monitor all of these devices, as we always do.”
Corrective actions included retraining the manufacturer on the specifications and the process, as well as ensuring that “everyone on that side understands what happens when we don’t do this right,” Ebeling says.
Notifying Impacted Patients and Physicians
The 21 impacted patients in the US received a signature-required certified letter detailing the recall, next steps, and that they will have no out-of-pocket costs related to it. “All 21 signed for it,” Ebeling says.
The sleep surgeon and sleep physician of record for each of these patients received a letter too (also sent via signature-required certified mail). Also, Inspire’s local representatives met with each physician to confirm receipt. “Our local team attests that the physicians got and understood the letter,” Ebeling says.
All in all, the limited scope, lack of need for immediate replacement, and the multi-step notification process are likely to lower patient and physician anxiety surrounding the Inspire IV pulse generator lot recall. I certainly hope so, and I think Inspire executives hope so too. As Ebeling told me, “Our number-one concern is patients and physicians get this managed.”
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