Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number/GTIN: 221604935 00613994445384; 221827829 00613994445384; 222121359 00613994445384; 222125124 00613994445384; 222163140 00613994445384 222163787 00613994445384; 222163788 00613994445384; 222204095 00613994445384; 222204097 00613994445384; 222439027 00613994445384; 222439028 00613994445384; 222439029 00613994445384 222658560 00613994445384; 222658561 00613994445384; 222724791 00613994445384; 222724792 00613994445384; 222766469 00613994445384; 222766470 00613994445384; 222816525 00613994445384; 222817386 00613994445384; 222817387 00613994445384 223818451 00763000624781; 223818452 00763000624781; 223954944 00763000624781; 223956932 00763000624781; 224083877 00613994445384; 224303373 00613994445384; 224303374 00613994445384; 225336444 00613994445384; 225468102 00613994445384; 226242272 00763000624781; 226366038 00613994445384; 226420633 00613994445384; 226420634 00763000624781; 226490981 00613994445384; 226517901 00613994445384; 226546796 00763000624781; 226571114 00763000624781; 226625848 00763000624781; 226632942 00763000624781; 226634688 00763000624781; 226634689 00763000624781; 226634690 00763000624781; 226665393 00763000624781; 226665394 00613994445384; 226665399 00763000624781; 226665400 00763000624781; 226665401 00763000624781; 226665403 00763000624781; 226665404 00763000624781; 226665405 00763000624781; 226665646 00763000624781; 226665647 00763000624781; 226665648 00763000624781; 226665650 00763000624781; 226732001 00763000624781; 226899377 00613994445384; 226951465 00613994445384; 226951467 00613994445384; 226951468 00613994445384; 226951469 00763000396008; 227136777 00763000624781; 227188108 00763000624781; 227194735 00763000624781; 227194736 00763000624781
- 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 Neurosurgery
- Reason for Recall:
- Potential for catheter disconnection from the patient line stopcock connectors.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
Product Codes/Lot Numbers:
Lot Number/GTIN: 221604935 00613994445384; 221827829 00613994445384; 222121359 00613994445384; 222125124 00613994445384; 222163140 00613994445384 222163787 00613994445384; 222163788 00613994445384; 222204095 00613994445384; 222204097 00613994445384; 222439027 00613994445384; 222439028 00613994445384; 222439029 00613994445384 222658560 00613994445384; 222658561 00613994445384; 222724791 00613994445384; 222724792 00613994445384; 222766469 00613994445384; 222766470 00613994445384; 222816525 00613994445384; 222817386 00613994445384; 222817387 00613994445384 223818451 00763000624781; 223818452 00763000624781; 223954944 00763000624781; 223956932 00763000624781; 224083877 00613994445384; 224303373 00613994445384; 224303374 00613994445384; 225336444 00613994445384; 225468102 00613994445384; 226242272 00763000624781; 226366038 00613994445384; 226420633 00613994445384; 226420634 00763000624781; 226490981 00613994445384; 226517901 00613994445384; 226546796 00763000624781; 226571114 00763000624781; 226625848 00763000624781; 226632942 00763000624781; 226634688 00763000624781; 226634689 00763000624781; 226634690 00763000624781; 226665393 00763000624781; 226665394 00613994445384; 226665399 00763000624781; 226665400 00763000624781; 226665401 00763000624781; 226665403 00763000624781; 226665404 00763000624781; 226665405 00763000624781; 226665646 00763000624781; 226665647 00763000624781; 226665648 00763000624781; 226665650 00763000624781; 226732001 00763000624781; 226899377 00613994445384; 226951465 00613994445384; 226951467 00613994445384; 226951468 00613994445384; 226951469 00763000396008; 227136777 00763000624781; 227188108 00763000624781; 227194735 00763000624781; 227194736 00763000624781
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1164-2024
Related Recalls
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Potential for catheter disconnection from the patient line stopcock connectors.