🔍 RecallPedia

SynchroMed II Infusion Pump. Product Number: 8637-20

Class I - Dangerous
🏥 Medical Devices Recalled: September 11, 2024 Medtronic Neuromodulation Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    GTIN Number: 00643169630505. Serial Number: NGP004814H
  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:
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

SynchroMed II Infusion Pump. Product Number: 8637-20

Product Codes/Lot Numbers:

GTIN Number: 00643169630505. Serial Number: NGP004814H

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0137-2025

Related Recalls

Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C; 4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D; 5. PROG CT900E CLINICIAN TABLET GLBL SMSNG, Model Number CT900E; 6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump

Medtronic Neuromodulation

Class I - Dangerous

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 →