Recall: Inspire IV Implantable Pulse Generator

Photo Credit: GGD News x Inspire Medical Systems Inc.

<KEY RECALL STATS>

Reason:

The IPG medical device has a manufacturing defect that can cause death or injury for patients. The IPG device is implanted by physicians and used to help control the upper airway during sleep. View the full list of affected models here.

Date of Recall:

June 17, 2024 (Company). FDA made official announcement on July 8, 2024.

Location: United States

Manufacturer:

Inspire Medical Systems Inc.

Next Steps:

Follow the FDA’s reporting recommendations. Along with details of the recall, the FDA has released a complete guide for both patients and medical professionals.

<Latest Recall News for IPG Devices>

• This Week at FDA: New guidances, upcoming meetings and several recalls – Regulatory Focus
  July 12, 2024
  This Week at FDA: New guidances, upcoming meetings and several recalls  Regulatory Focus
• Cisco Declines 9.4% Year to Date: How to Play CSCO Stock Now? – Zacks Investment Research
  July 10, 2024
  Cisco Declines 9.4% Year to Date: How to Play CSCO Stock Now?  Zacks Investment Research
• Inspire Medical (INSP) Dips on FDA Recall of IPG Model 3028 – Yahoo Finance
  July 10, 2024
  Inspire Medical (INSP) Dips on FDA Recall of IPG Model 3028  Yahoo Finance
• Recall of Inspire IV Implantable Pulse Generator Due to Defect – Franklin County Free Press
  July 9, 2024
  Recall of Inspire IV Implantable Pulse Generator Due to Defect  Franklin County Free Press
• FDA Labels Inspire Medical's Sleep Apnea Nerve Stimulator Recall As Most Serious – Benzinga
  July 9, 2024
  FDA Labels Inspire Medical's Sleep Apnea Nerve Stimulator Recall As Most Serious  Benzinga

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