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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Medtronic Neurosurgery: External Drainage Systems Recalled for Potential Catheter Disconnection

Agency Publication Date: February 27, 2024
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Summary

Medtronic Neurosurgery is recalling approximately 89,097 units of the Duet External Drainage and Monitoring System across various configurations, including models with Interlink and SmartSite injection sites. These devices, which are used to drain cerebrospinal fluid (CSF) from the brain or spine to reduce pressure, are being recalled because the catheter may disconnect from the patient line stopcock connectors. If a disconnection occurs, it could result in the leakage of brain fluid, the introduction of air into the nervous system, or the potential for infection. Consumers should contact their healthcare provider or Medtronic for further instructions on how to handle affected units.

Risk

A disconnection between the catheter and the patient line stopcock can lead to uncontrolled drainage of cerebrospinal fluid or the entry of external contaminants and air into the system. This poses a critical risk of infection (meningitis), neurological injury, or even death if the underlying intracranial pressure is not properly managed.

What You Should Do

  1. Identify if you have any Medtronic Duet External Drainage and Monitoring Systems with the following Reference (REF) numbers: 46913, 46914, 46915, 46916, or 46917.
  2. Check the packaging or device labels for specific lot numbers such as 221482527, 221569956, 221569957, 223564705, 227136767, or any of the over 500 specific lot codes listed in the recall documentation.
  3. Inspect the GTIN barcodes on the product labels to confirm a match, including codes like 00613994445360, 00763000406004, 00763000395971, 00763000624774, and 00763000624781.
  4. If you are a patient currently using this system, contact your neurosurgeon or healthcare provider immediately to discuss the risks and ensure the system is properly connected and monitored.
  5. Healthcare facilities should isolate any unused affected stock and contact Medtronic Neurosurgery at 5290 California Ave, Irvine, California, 92617-3073 for instructions on returning or replacing the devices.
  6. Contact Medtronic customer support or your local sales representative for further technical information or questions regarding the potential for catheter disconnection.
  7. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer consultation and system monitoring

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites
Model / REF:
REF 46913
UPC Codes:
00613994445360
00763000406004
00763000624767
Lot Numbers (117):
221482527
221569956
221569957
221614450
221614451
221614452
221687764
221744157
221744547
221795478
221873430
221955228
221955229
222061753
222061754
222082061
222121358
222186493
222186494
222186495
222240558
222240559
222240560
222274124
222274125
222322811
222322812
222322813
222580925
223564705
223659557
223659558
223734520
223778508
223818450
223999039
224032596
224197127
224218026
224218028
224255795
224277483
224302821
224333656
224878533
224918533
224918534
224918535
224918536
224949836
Product: Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites
Model / REF:
REF 46914
UPC Codes:
00763000395971
00613994445377
00763000624774
Lot Numbers (127):
221482529
221520718
221648854
221687765
221744158
221744549
221795479
221827827
221827828
221873427
221873428
221915124
221915125
221916163
221916164
221955230
221955231
222015665
222061755
222204094
222345104
222345105
222346067
222393929
222393930
222530273
222543362
222543363
222580924
222970856
222970857
222970858
222999295
222999296
223070846
223130156
223165960
223165961
223165962
223251949
223580360
223620063
223621055
223659559
223659560
223698571
223734521
223734522
223778509
223999041
Product: Medtronic Duet External Drainage System, Interlink, Ventricular Catheter
Model / REF:
REF 46915
UPC Codes:
00613994445384
00763000624781
00763000396008
Lot Numbers (65):
221604935
221827829
222121359
222125124
222163140
222163787
222163788
222204095
222204097
222439027
222439028
222439029
222658560
222658561
222724791
222724792
222766469
222766470
222816525
222817386
222817387
223818451
223818452
223954944
223956932
224083877
224303373
224303374
225336444
225468102
226242272
226366038
226420633
226420634
226490981
226517901
226546796
226571114
226625848
226632942
226634688
226634689
226634690
226665393
226665394
226665399
226665400
226665401
226665403
226665404
Product: Medtronic Duet External Drainage System, SmartSite, Ventricular Catheter
Model / REF:
REF 46916
UPC Codes:
00613994445391
00763000406011
00763000624798
Lot Numbers (67):
221343119
221612695
221873429
221873431
222082062
222480771
222480772
223565026
223580361
223580378
223618474
223621056
223659561
223907224
223907225
223956150
223999042
223999043
224032609
224128508
224387126
224852795
224852796
224878536
224949834
224949835
224990657
224990660
224990846
224990847
224990889
225198821
225500036
225500037
225675930
225675932
225686835
225749841
226111239
226242273
226288883
226335146
226335147
226335148
226366036
226420635
226420636
226517902
226567491
226616245
Product: Medtronic Duet External Drainage System, Interlink, Lumbar Catheter
Model / REF:
REF 46917
UPC Codes:
00613994445407
00763000624804
00763000406028
Lot Numbers:
222277587
223565027
223580362
223698572
223734523
223999040
224301720
224302820
224973997
224990852
224990870
224990871
225198822
226490967
226517899
226546799
226571115
226665388
226665395
226734688
226734689
226756273

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93919
Status: Active
Manufacturer: Medtronic Neurosurgery
Sold By: Authorized Medical Distributors; Specialty Healthcare Providers
Manufactured In: United States
Units Affected: 5 products (30,711 units; 32,404 units; 14,139 units; 11,840 units; 3, 889 units)
Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.