Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone.
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.
Why it was recalled
Potential for catheter disconnection from the patient line stopcock connectors.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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;
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and OUS (foreign): Argentina, Australia, Bahrain, Belgium, Bosnia And Herzegovina, Botswana, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, Gabon, Germany, Ghana, Greece, Hong Kong, Iceland, Iran, Islamic Republic Of Ireland, Italy, Kazakhstan, Kuwait, Latvia, Malaysia, Malta, Mauritius, Mexico, Namibia, Netherlands, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.
Recall record
- Recalling firm
- Medtronic Neurosurgery
- Product type
- Devices
- Recall number
- Z-1163-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Irvine, CA
- Recall initiated
- 2024-01-22
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1163-2024 · Source: openFDA enforcement.