Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

Class I - Dangerous

🏥 Medical Devices Recalled: January 22, 2024 Medtronic Neurosurgery Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
Lot Number/GTIN: 221482529 00763000395971; 221520718 00763000395971; 221648854 00763000395971; 221687765 00763000395971; 221744158 00763000395971; 221744549 00763000395971; 221795479 00613994445377; 221827827 00613994445377; 221827828 00613994445377; 221873427 00763000395971; 221873428 00763000395971; 221915124 00763000395971; 221915125 00763000395971; 221916163 00613994445377; 221916164 00763000395971; 221955230 00763000395971; 221955231 00763000395971; 222015665 00613994445377; 222061755 00613994445377; 222204094 00613994445377; 222345104 00613994445377; 222345105 00613994445377; 222346067 00613994445377; 222393929 00763000395971; 222393930 00763000395971; 222530273 00613994445377; 222543362 00763000395971; 222543363 00763000395971; 222580924 00613994445377; 222970856 00613994445377; 222970857 00613994445377; 222970858 00613994445377; 222999295 00613994445377; 222999296 00613994445377; 223070846 00763000395971; 223130156 00763000395971; 223165960 00763000395971; 223165961 00763000395971; 223165962 00763000395971; 223251949 00763000395971; 223580360 00763000624774; 223620063 00763000624774; 223621055 00763000624774; 223659559 00763000624774; 223659560 00763000624774; 223698571 00763000624774; 223734521 00763000624774; 223734522 00763000624774; 223778509 00763000624774; 223999041 00613994445377; 224032597 00763000624774; 224173197 00763000395971; 224342656 00763000395971; 224387139 00763000395971; 224852792 00763000624774; 224852793 00763000624774; 224852794 00763000624774; 224877792 00763000624774; 224878534 00763000624774; 224878535 00763000624774; 224918537 00763000624774; 224949833 00613994445377; 224990656 00763000624774; 224990658 00613994445377; 224990659 00613994445377; 224990661 00613994445377; 224990664 00763000624774; 224990665 00763000624774; 224990851 00763000624774; 224990869 00763000624774; 224990887 00763000624774; 224990888 00763000624774; 225035347 00763000624774; 225234319 00763000395971; 225279761 00763000395971; 225422433 00763000624774; 225468089 00763000395971; 225500028 00763000395971; 225558568 00613994445377; 225587871 00763000395971; 225587872 00763000395971; 225587873 00763000624774; 225587874 00763000624774; 225749839 00763000395971; 225749840 00763000624774; 226111272 00763000395971; 226242266 00763000624774; 226242267 00763000624774; 226242268 00763000624774; 226242269 00763000624774; 226288881 00763000624774; 226288882 00763000624774; 226335063 00763000624774; 226335064 00763000624774; 226335065 00763000624774; 226366037 00613994445377; 226420630 00613994445377; 226420631 00763000395971; 226420632 00763000624774; 226490978 00613994445377; 226490979 00613994445377; 226517897 00763000624774; 226517898 00763000624774; 226567488 00763000624774; 226567489 00763000624774; 226567490 00763000624774; 226567492 00763000624774; 226616244 00763000624774; 226616246 00763000395971; 226756270 00763000395971; 226756271 00763000624774; 226756272 00763000624774; 226810274 00763000624774; 226899370 00763000395971; 226899372 00763000624774; 226951461 00763000395971; 226951462 00763000395971; 226951463 00763000624774; 226951464 00763000624774; 227006497 00763000624774; 227007687 00763000624774; 227136770 00763000624774; 227188107 00763000624774; 227289116 00763000395971; 227289117 00763000395971; 227307929 00763000624774; 227387373 00763000624774;
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, SmartSite, Injection Sites, REF 46914, 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: 221482529 00763000395971; 221520718 00763000395971; 221648854 00763000395971; 221687765 00763000395971; 221744158 00763000395971; 221744549 00763000395971; 221795479 00613994445377; 221827827 00613994445377; 221827828 00613994445377; 221873427 00763000395971; 221873428 00763000395971; 221915124 00763000395971; 221915125 00763000395971; 221916163 00613994445377; 221916164 00763000395971; 221955230 00763000395971; 221955231 00763000395971; 222015665 00613994445377; 222061755 00613994445377; 222204094 00613994445377; 222345104 00613994445377; 222345105 00613994445377; 222346067 00613994445377; 222393929 00763000395971; 222393930 00763000395971; 222530273 00613994445377; 222543362 00763000395971; 222543363 00763000395971; 222580924 00613994445377; 222970856 00613994445377; 222970857 00613994445377; 222970858 00613994445377; 222999295 00613994445377; 222999296 00613994445377; 223070846 00763000395971; 223130156 00763000395971; 223165960 00763000395971; 223165961 00763000395971; 223165962 00763000395971; 223251949 00763000395971; 223580360 00763000624774; 223620063 00763000624774; 223621055 00763000624774; 223659559 00763000624774; 223659560 00763000624774; 223698571 00763000624774; 223734521 00763000624774; 223734522 00763000624774; 223778509 00763000624774; 223999041 00613994445377; 224032597 00763000624774; 224173197 00763000395971; 224342656 00763000395971; 224387139 00763000395971; 224852792 00763000624774; 224852793 00763000624774; 224852794 00763000624774; 224877792 00763000624774; 224878534 00763000624774; 224878535 00763000624774; 224918537 00763000624774; 224949833 00613994445377; 224990656 00763000624774; 224990658 00613994445377; 224990659 00613994445377; 224990661 00613994445377; 224990664 00763000624774; 224990665 00763000624774; 224990851 00763000624774; 224990869 00763000624774; 224990887 00763000624774; 224990888 00763000624774; 225035347 00763000624774; 225234319 00763000395971; 225279761 00763000395971; 225422433 00763000624774; 225468089 00763000395971; 225500028 00763000395971; 225558568 00613994445377; 225587871 00763000395971; 225587872 00763000395971; 225587873 00763000624774; 225587874 00763000624774; 225749839 00763000395971; 225749840 00763000624774; 226111272 00763000395971; 226242266 00763000624774; 226242267 00763000624774; 226242268 00763000624774; 226242269 00763000624774; 226288881 00763000624774; 226288882 00763000624774; 226335063 00763000624774; 226335064 00763000624774; 226335065 00763000624774; 226366037 00613994445377; 226420630 00613994445377; 226420631 00763000395971; 226420632 00763000624774; 226490978 00613994445377; 226490979 00613994445377; 226517897 00763000624774; 226517898 00763000624774; 226567488 00763000624774; 226567489 00763000624774; 226567490 00763000624774; 226567492 00763000624774; 226616244 00763000624774; 226616246 00763000395971; 226756270 00763000395971; 226756271 00763000624774; 226756272 00763000624774; 226810274 00763000624774; 226899370 00763000395971; 226899372 00763000624774; 226951461 00763000395971; 226951462 00763000395971; 226951463 00763000624774; 226951464 00763000624774; 227006497 00763000624774; 227007687 00763000624774; 227136770 00763000624774; 227188107 00763000624774; 227289116 00763000395971; 227289117 00763000395971; 227307929 00763000624774; 227387373 00763000624774;