Inspire Medical Systems, Inc. Removes Implantable Pulse Generator
WEBJul 8, 2024 · Inspire Medical Systems Inc. is recalling Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect. This defect can cause system malfunctions after...
Class 2 Device Recall Inspire II Model 3024 Implantable Pulse Generator ...
WEBJun 12, 2018 · Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway...
Class 1 Device Recall Inspire Model 3028 Implantable Pulse …
WEBMay 16, 2024 · Inspire Medical systems issued an URGENT Medical Device Correction notice to the affected healthcare providers on 05/16/2024 via FedEx overnight.
FDA amplifies Inspire Medical's sleep apnea nerve stimulator recall
WEBJul 9, 2024 · The FDA has elevated a recall of Inspire Medical’s nerve-stimulating implant for the treatment of obstructive sleep apnea. The agency handed down a Class I recall designation to the effort,...
FDA Labels Inspire Medical's Sleep Apnea Nerve Stimulator Recall ... - MSN
WEBThe FDA has labeled a recall of Inspire Medical Systems, Inc.’s (NYSE:INSP) nerve-stimulating implant for obstructive sleep apnea as Class I, the most serious kind. Inspire initiated a...
Inspire Recalls Key Component of Neurostimulator Therapy for OSA
WEBJul 8, 2024 · Inspire Medical Systems is recalling Inspire IV implantable pulse generator model 3028, a key component of the Inspire upper airway stimulation system for treating obstructive sleep apnea, due to a manufacturing defect.
Inspire IV Implantable Pulse Generator Model 3028 Recalled - U.S.
WEBJul 8, 2024 · Inspire Medical Systems Inc. is recalling Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect. This defect can cause system malfunctions after implantation, leading to electrical leakage in the sensing circuit.
Key Component of Inspire Therapy for Sleep Apnea Recalled
WEBJul 8, 2024 · Inspire Medical Systems is recalling Inspire IV implantable pulse generator model 3028, a key component of the Inspire upper airway stimulation system for treating obstructive sleep apnea, due to a manufacturing defect.
Inspire Medical Systems Recalls Implantable Pulse Generator - Medscape
WEBJul 16, 2024 · Inspire Medical Systems has issued a recall for the Inspire IV Implantable Pulse Generator (IPG) Model 3028 because of a manufacturing defect that could disrupt therapy and cause serious...
Class 2 Device Recall INSPIRE 8 hollow fiber oxygenator with …
WEBMar 13, 2018 · for Recall: Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath...