A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial numbers NPL3011706 and NPL3016791, UDI-DI 643169738058.
  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:
Medtronic Neuromodulation
Reason for Recall:
When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..

Product Codes/Lot Numbers:

Serial numbers NPL3011706 and NPL3016791, UDI-DI 643169738058.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2226-2023

Related Recalls

Class I - Dangerous

Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.

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