🔍 RecallPedia

Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product Usage: The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity, Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer

Class I - Dangerous
🏥 Medical Devices Recalled: October 3, 2016 Medtronic Neuromodulation Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    software application cards with versions other than AAU01
  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:
Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software application card (to version AAU01) and the SynchroMed pump labeling to address the priming bolus issue.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product Usage: The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity, Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer

Product Codes/Lot Numbers:

software application cards with versions other than AAU01

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0788-2017

Related Recalls

Enhanced Verify Evaluation Handset (CFN HH90130FA)

Medtronic Neuromodulation

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.

Apr 3, 2025 Other Medical Devices Nationwide View Details →