Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot No. 206923217 207096627 207096630 207187691 207224897 207269986 207466017 207565424 207565425 207659575 207659576 207739874 207875274 207945037 207982847
  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 Neurosurgery
Reason for Recall:
Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.

Product Codes/Lot Numbers:

Lot No. 206923217 207096627 207096630 207187691 207224897 207269986 207466017 207565424 207565425 207659575 207659576 207739874 207875274 207945037 207982847

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1920-2014

Related Recalls

Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

Nov 1, 2024 Diagnostic Equipment Nationwide View Details →

Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

Nov 1, 2024 Diagnostic Equipment Nationwide View Details →