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Inspire device recall
#1
Inspire device recall
https://www.fda.gov/medical-devices/medi...65#devices

Quote:An Implantable Hypoglossal Nerve Stimulator Device Removal: Inspire Medical Systems, Inc. Removes Inspire IV Implantable Pulse Generator due to Manufacturing Defect That Can Result in System Malfunctions

happened a month ago hopefully no one from here got affected?
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#2
RE: Inspire device recall
There have been several threads over the last couple years on folk using the Inspire implant.  Here is one of the largest threads, but I haven't seen any recent updates.

https://www.apneaboard.com/forums/Thread...ht=Inspire
OpalRose
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#3
RE: Inspire device recall
Wowzers. Imagine having an implant that may or may not be doing the wrong thing to your breathing while asleep. Scary!
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#4
RE: Inspire device recall
My wife called her doctor's office yesterday to see if her implant was one of the affected units, and the office didn't even know about the recall(!)  Maybe they only notified surgeons who installed affected units, trying to keep it quiet.

Luckily we found a report with the unit S/N, and hers is not affected from what we can see.
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#5
RE: Inspire device recall
There was an incredibly damning report of Inspire Medical Systems by Wolfpack Research, regarding both the company itself and the product. I would encourage anyone with an interest in the Inspire implant to download the full report and look it over, especially the long list of adverse effects and complaints, as well as all the lifestyle restrictions that come with the device. This report was from 2020 - I don't know what may have changed with the company or device since then.
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#6
RE: Inspire device recall
When I first came here to ApneaBoard, I had failed compliance with my ST (A) and had one visit with my ENT who said that he could try to contact my insurance and get the Inspire implant for me.  I had no clue about sleep apnea treatment or Inspire. 

Sleeprider directed me to search our archives here to make up my own mind on Inspire.  I did a search here and did my own independent research also.  I decided not to have the Inspire based on my research. 

That said, I have read where some people who have had the Inspire like it; and it seems to be a long term solution for them.  

The "Search" here at ApneaBoard is a treasure trove of honest experiences with different machines, masks, devices like Inspire, etc.  Also, at the bottom of every thread there is a "Possibly Related Threads" feature to quickly access some threads to help  with clarification or comparison.  And there is the "Product Review Forum" here also.
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#7
RE: Inspire device recall
My Goodness!
I survived the Phillips recall in July, 2021, after logging 9200 hours on a Phillips Dream Maker machine. (and had 2 lung xrays to see if I'm injured)

Never thought this would occur. I'm now glad my AHI was not high enough for the required 15+ for Inspire.

Who can one trust anymore? It seems not the "professionals".
PAP Mode: VPAP-S
EPAP 8.4 IPAP 10.6 
ave AHI = .5 (so far)
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#8
RE: Inspire device recall
I see the Inspire commercials on tv all the time. Funny thing, they don't make mention of any recalls.  Big Grin
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