Home / Recalls / Medtronic Neurosurgery / Z-1165-2024

Z-1165-2024 Class I Ongoing

Recalled by Medtronic Neurosurgery — Irvine, CA

Recall Details

Product Type
Devices
Report Date
March 6, 2024
Initiation Date
January 22, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,840 units

Product Description

Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

Reason for Recall

Potential for catheter disconnection from the patient line stopcock connectors.

Distribution Pattern

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.

Code Information

Lot Number/GTIN: 221343119 00613994445391; 221612695 00613994445391; 221873429 00613994445391; 221873431 00763000406011; 222082062 00613994445391; 222480771 00763000406011; 222480772 00763000406011; 223565026 00763000624798; 223580361 00763000624798; 223580378 00763000624798; 223618474 00763000624798; 223621056 00763000624798; 223659561 00763000624798; 223907224 00613994445391; 223907225 00613994445391; 223956150 00613994445391; 223999042 00613994445391; 223999043 00613994445391; 224032609 00613994445391; 224128508 00763000406011; 224387126 00763000406011; 224852795 00613994445391; 224852796 00613994445391; 224878536 00613994445391; 224949834 00613994445391; 224949835 00613994445391; 224990657 00763000624798; 224990660 00613994445391; 224990846 00613994445391; 224990847 00763000624798; 224990889 00763000624798; 225198821 00613994445391; 225500036 00613994445391; 225500037 00613994445391; 225675930 00763000406011; 225675932 00613994445391; 225686835 00613994445391; 225749841 00763000406011; 226111239 00613994445391; 226242273 00763000624798; 226288883 00763000624798; 226335146 00613994445391; 226335147 00763000624798; 226335148 00613994445391; 226366036 00763000624798; 226420635 00763000406011; 226420636 00763000624798; 226517902 00613994445391; 226567491 00763000624798; 226616245 00763000624798; 226734637 00763000624798; 226734639 00763000624798; 226734641 00763000624798; 226734643 00763000624798; 226734645 00763000624798; 226734686 00763000624798; 226756274 00613994445391; 226899371 00763000406011; 226899373 00763000624798; 226899375 00613994445391; 226899378 00613994445391; 226899379 00613994445391; 226899380 00613994445391; 227007688 00763000406011; 227136780 00763000624798; 227188109 00763000624798; 227307931 00763000406011

Other recalls by Medtronic Neurosurgery

  • Z-0661-2025 Class I — Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SI (November 1, 2024)
  • Z-0662-2025 Class I — Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VC (November 1, 2024)
  • Z-1162-2024 Class I — Medtronic Duet External Drainage and Monitoring System, Interlink Injection Site (January 22, 2024)
  • Z-1166-2024 Class I — Medtronic Duet External Drainage and Monitoring System, Interlink Injection Site (January 22, 2024)
  • Z-1164-2024 Class I — Medtronic Duet External Drainage and Monitoring System, Interlink Injection Site (January 22, 2024)
  • Z-1163-2024 Class I — Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sit (January 22, 2024)
  • Z-2412-2023 Class II — Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Inje (June 28, 2023)
  • Z-2207-2023 Class II — Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUR (June 13, 2023)
  • Z-1116-2021 Class II — Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valv (January 11, 2021)
  • Z-1117-2021 Class II — Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the fo (January 11, 2021)