Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Number/GTIN: 221482527 00613994445360; 221569956 00763000406004; 221569957 00763000406004; 221614450 00613994445360; 221614451 00613994445360; 221614452 00613994445360; 221687764 00763000406004; 221744157 00763000406004; 221744547 00763000406004; 221795478 00613994445360; 221873430 00763000406004; 221955228 00763000406004; 221955229 00763000406004; 222061753 00763000406004; 222061754 00763000406004; 222082061 00613994445360; 222121358 00613994445360; 222186493 00613994445360; 222186494 00613994445360; 222186495 00613994445360; 222240558 00613994445360; 222240559 00613994445360; 222240560 00613994445360; 222274124 00613994445360; 222274125 00613994445360 222322811 00763000406004; 222322812 00763000406004; 222322813 00763000406004; 222580925 00763000406004; 223564705 00763000624767; 223659557 00763000624767; 223659558 00763000624767;; 223734520 00763000624767; 223778508 00763000624767; 223818450 00763000624767; 223999039 00763000406004; 224032596 00763000406004; 224197127 00763000406004; 224218026 00763000406004; 224218028 00763000406004; 224255795 00763000406004; 224277483 00763000406004; 224302821 00763000406004; 224333656 00613994445360; 224878533 00763000624767; 224918533 00763000406004; 224918534 00763000624767; 224918535 00763000624767; 224918536 00763000624767; 224949836 00763000406004; 224949837 00763000406004; 224973998 00763000624767; 224973999 00763000624767; 224990662 00763000406004; 224990663 00763000624767; 224990848 00763000406004; 224990849 00763000624767; 224990850 00763000624767; 224990867 00763000624767; 224990868 00763000624767; 224990886 00763000624767; 225035261 00763000406004; 225234318 00763000406004; 225279760 00763000406004; 225336442 00613994445360; 225336443 00613994445360; 225375797 00763000406004; 225375798 00763000406004 225419717 00763000406004; 225422438 00763000406004; 225468101 00613994445360; 225558567 00763000406004; 225559817 00763000406004; 225559818 00763000406004 225587869 00763000406004; 225587870 00763000406004; 225749838 00763000406004; 226091713 00763000406004; 226111273 00763000406004; 226242270 00763000624767; 226242271 00763000624767; 226288880 00763000624767; 226335061 00763000406004; 226335062 00763000624767; 226467306 00763000624767; 226490966 00763000624767 226517895 00763000624767; 226517896 00763000624767; 226517900 00763000406004; 226546791 00763000624767; 226546794 00763000624767; 226571112 00763000624767; 226571113 00763000624767; 226650893 00763000624767; 226650894 00763000624767; 226665390 00763000406004; 226665391 00763000406004; 226665392 00763000406004; 226689508 00763000624767; 226711355 00763000406004; 226711356 00763000406004; 226711357 00763000406004; 226738254 00763000406004; 226738255 00763000406004; 226738256 00763000406004; 226738257 00763000406004; 226899374 00613994445360; 227136767 00763000624767; 227136768 00763000624767; 227136769 00763000624767; 227187464 00763000624767; 227187465 00763000624767; 227188106 00763000624767; 227194730 00763000624767; 227289113 00763000406004; 227289114 00763000406004; 227289115 00763000406004
  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:
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, REF 46913, 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: 221482527 00613994445360; 221569956 00763000406004; 221569957 00763000406004; 221614450 00613994445360; 221614451 00613994445360; 221614452 00613994445360; 221687764 00763000406004; 221744157 00763000406004; 221744547 00763000406004; 221795478 00613994445360; 221873430 00763000406004; 221955228 00763000406004; 221955229 00763000406004; 222061753 00763000406004; 222061754 00763000406004; 222082061 00613994445360; 222121358 00613994445360; 222186493 00613994445360; 222186494 00613994445360; 222186495 00613994445360; 222240558 00613994445360; 222240559 00613994445360; 222240560 00613994445360; 222274124 00613994445360; 222274125 00613994445360 222322811 00763000406004; 222322812 00763000406004; 222322813 00763000406004; 222580925 00763000406004; 223564705 00763000624767; 223659557 00763000624767; 223659558 00763000624767;; 223734520 00763000624767; 223778508 00763000624767; 223818450 00763000624767; 223999039 00763000406004; 224032596 00763000406004; 224197127 00763000406004; 224218026 00763000406004; 224218028 00763000406004; 224255795 00763000406004; 224277483 00763000406004; 224302821 00763000406004; 224333656 00613994445360; 224878533 00763000624767; 224918533 00763000406004; 224918534 00763000624767; 224918535 00763000624767; 224918536 00763000624767; 224949836 00763000406004; 224949837 00763000406004; 224973998 00763000624767; 224973999 00763000624767; 224990662 00763000406004; 224990663 00763000624767; 224990848 00763000406004; 224990849 00763000624767; 224990850 00763000624767; 224990867 00763000624767; 224990868 00763000624767; 224990886 00763000624767; 225035261 00763000406004; 225234318 00763000406004; 225279760 00763000406004; 225336442 00613994445360; 225336443 00613994445360; 225375797 00763000406004; 225375798 00763000406004 225419717 00763000406004; 225422438 00763000406004; 225468101 00613994445360; 225558567 00763000406004; 225559817 00763000406004; 225559818 00763000406004 225587869 00763000406004; 225587870 00763000406004; 225749838 00763000406004; 226091713 00763000406004; 226111273 00763000406004; 226242270 00763000624767; 226242271 00763000624767; 226288880 00763000624767; 226335061 00763000406004; 226335062 00763000624767; 226467306 00763000624767; 226490966 00763000624767 226517895 00763000624767; 226517896 00763000624767; 226517900 00763000406004; 226546791 00763000624767; 226546794 00763000624767; 226571112 00763000624767; 226571113 00763000624767; 226650893 00763000624767; 226650894 00763000624767; 226665390 00763000406004; 226665391 00763000406004; 226665392 00763000406004; 226689508 00763000624767; 226711355 00763000406004; 226711356 00763000406004; 226711357 00763000406004; 226738254 00763000406004; 226738255 00763000406004; 226738256 00763000406004; 226738257 00763000406004; 226899374 00613994445360; 227136767 00763000624767; 227136768 00763000624767; 227136769 00763000624767; 227187464 00763000624767; 227187465 00763000624767; 227188106 00763000624767; 227194730 00763000624767; 227289113 00763000406004; 227289114 00763000406004; 227289115 00763000406004

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1162-2024

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 →