A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    version v.2x, UDI/DI 00763000632793
  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:
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.

Product Codes/Lot Numbers:

version v.2x, UDI/DI 00763000632793

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1506-2025

Related Recalls

Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.

Apr 8, 2026 Implants & Prosthetics View Details →