Duet recallZ-1166-2024 · Medtronic Neurosurgery · initiated Jan 22, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neurosurgery or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for catheter disconnection from the patient line stopcock connectors.
FDA root cause category: Under Investigation by firm
What the company is doing
On January 23, 2024, Medtronic CSF issued a "URGENT: MEDICAL DEVICE RECALL" Notification to affected consignees via mail. Medtronic CSF asked consignees to take the following actions: 1. Immediately identify and quarantine any unused impacted product(s). 2. Return all unused and non-expired product(s) in your inventory to Medtronic. Your Medtronic Sales Representative can assist in returning any affected consignment and loaner inventory, if applicable. 3. Work with your Medtronic Rep to receive an RGA# or contact us at 1-800-874-5797, Option 1, to coordinate inventory replacement/credit. Reference FA1400, Lot Number, and Product Number. 4. Reference the RGA# in the attention line when returning the affected product. Credit for products returned without an RGA# may be delayed. 5. Return unopened affected units to: Medtronic, Attention: [Insert RGA #], 4340 Swinnea Rd., Building B, Returns cage, Memphis, TN 38118 6. Complete and return the Customer Confirmation Form, even if you do not have any unused affected product to return via email to [email protected] within 30 days of receipt. If you have any questions regarding this communication, please contact your Medtronic representative.
Recall details
- Recall number
- Z-1166-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 22, 2024
- Posted by the FDA
- Feb 27, 2024
- Recalling firm
- Medtronic Neurosurgery
- Quantity
- 3, 889 units
- Product code
- PCB
- 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.
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Duet® 46917Medtronic Ps Medical, Inc. · DEVICE, MONITORING, INTRACRANIAL PRESSURE1 recall5 reports
- Duet® 46917Medtronic Ps Medical, Inc. · External cerebrospinal fluid (CSF) diversion1 recall0 reports
- Duet® 46917Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93919).
- Z-1162-2024 · Open, ClassifiedMedtronic 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 intr…
- Z-1163-2024 · Open, ClassifiedMedtronic 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 int…
- Z-1164-2024 · Open, ClassifiedMedtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as …
- Z-1165-2024 · Open, ClassifiedMedtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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