SynchroMed II implantable drug infusion pump, Model 8637-40,
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Number NGV526743H
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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 received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from updating the pump; however the pump was providing therapy.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SynchroMed II implantable drug infusion pump, Model 8637-40,
Product Codes/Lot Numbers:
Serial Number NGV526743H
Distribution:
Distributed in: IL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1694-2017
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