🔍 RecallPedia

Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

Class I - Dangerous
🏥 Medical Devices Recalled: July 31, 2024 Inspire Medical Systems Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model 4340. UDI-DI: 10855728005946. Part Number: 900-014-00. Serial Numbers: D59544, D59550, D59543, D59541, D59542, D59528, D59526, D59534, D59521, D59477, D59519, D59515, D59516, D59489, D59514, D59512, D59510, D59509, D59547, D59549, D59505, D59506, D59504, D59503, D59502, D59529, D59497, D59494, D59490, D59485, D59486, D56077, D56072, D56064, D56060, D56059, D56055, D56038, D56082, D56035, D56044, D56031, D56032, D56033, D56034, D56040, D56046, D56030, D56036, D56053, D56054, D56058, D55284, D48681, D48668, D48661, D48655, D48650, D48410, D46477, D46478, D43687, D43688, D43700, D48014, D48007, D47994, D47991, D47983, D47964, D47963, D47958, D47940, D45763, D47939, D45768, D47913, D47228, D47903, D47896, D47897, D47909, D47910, D47951, D45706, D45721, D45724, D47877, D47872, D47879, D47880, D47691, D47670, D47654, D47243, D47240, D47220, D47187, D47181, D47176, D47177, D47191, D47192, D47175, D47169, D47163, D47164, D47142, D47131, D47926, D47102, D47013, D47006, D46990, D46966, D46955, D46854, D46855, D46847, D46846, D46835, D46804, D46797, D46784, D47202, D46699, D46700, D46664, D46566, D46567, D46561, D46535, D46532, D46527, D46528, D46529, D46525, D46526, D46463, D46451, D45962, D45949, D45947, D45777, D45773, D45745, D45708, D44687, D44685, D44677, D44675, D26997.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Inspire Medical Systems Inc.
Reason for Recall:
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

Product Codes/Lot Numbers:

Model 4340. UDI-DI: 10855728005946. Part Number: 900-014-00. Serial Numbers: D59544, D59550, D59543, D59541, D59542, D59528, D59526, D59534, D59521, D59477, D59519, D59515, D59516, D59489, D59514, D59512, D59510, D59509, D59547, D59549, D59505, D59506, D59504, D59503, D59502, D59529, D59497, D59494, D59490, D59485, D59486, D56077, D56072, D56064, D56060, D56059, D56055, D56038, D56082, D56035, D56044, D56031, D56032, D56033, D56034, D56040, D56046, D56030, D56036, D56053, D56054, D56058, D55284, D48681, D48668, D48661, D48655, D48650, D48410, D46477, D46478, D43687, D43688, D43700, D48014, D48007, D47994, D47991, D47983, D47964, D47963, D47958, D47940, D45763, D47939, D45768, D47913, D47228, D47903, D47896, D47897, D47909, D47910, D47951, D45706, D45721, D45724, D47877, D47872, D47879, D47880, D47691, D47670, D47654, D47243, D47240, D47220, D47187, D47181, D47176, D47177, D47191, D47192, D47175, D47169, D47163, D47164, D47142, D47131, D47926, D47102, D47013, D47006, D46990, D46966, D46955, D46854, D46855, D46847, D46846, D46835, D46804, D46797, D46784, D47202, D46699, D46700, D46664, D46566, D46567, D46561, D46535, D46532, D46527, D46528, D46529, D46525, D46526, D46463, D46451, D45962, D45949, D45947, D45777, D45773, D45745, D45708, D44687, D44685, D44677, D44675, D26997.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0040-2025

Related Recalls

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 Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).

Inspire Medical Systems

Class I - Dangerous

Incorrect use-by date on the device registration/patient file labels.

Jun 12, 2018 Implants & Prosthetics Nationwide View Details →