Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile E
Summary
The FDA issued a Class I for Medtronic Duet External Drainage and Monitoring System, Interlink Injection Site by Medtronic Neurosurgery. Reason: Potential for catheter disconnection from the patient line stopcock connectors..
Details
Source
Device Recall
External ID
Z-1166-2024
Action Date
2024-03-06
Status
Ongoing
Category
device
Product Description
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
Lot/Code Info: Lot Number/GTIN: 222277587 00613994445407; 223565027 00763000624804; 223580362 00763000624804; 223698572 00763000624804; 223734523 00763000624804; 223999040 00763000406028; 224301720 00763000406028; 224302820 00613994445407; 224973997 00613994445407; 224990852 00613994445407; 224990870 00613994445407; 224990871 00613994445407; 225198822 00613994445407; 226490967 00763000624804; 226517899 00763000624804; 226546799 00613994445407; 226571115 00613994445407; 226665388 00763000624804; 226665395 00613994445407; 226734688 00763000624804; 226734689 00763000624804; 226756273 00763000406028
Quantity Affected: 3, 889 units
Reason for Recall
Potential for catheter disconnection from the patient line stopcock connectors.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-22
Company
Irvine, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 205 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Neurosurgery has 12 FDA actions in our database, including 9 recalls and 3 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Neurosurgery) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Neurosurgery have FDA actions?
Medtronic Neurosurgery has 12 FDA actions in our database, including 9 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1166-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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