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Recall Observatory FDA recall evidence

Device product

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.

Z-1166-2024

January 22, 2024

Class I

Product summary

Firm
Medtronic Neurosurgery
Event
Event 93919
Status
Ongoing
Classification
Class I
Quantity
3, 889 units
Official record key
device-enforcement:Z-1166-2024

Official wording

Reason: Potential for catheter disconnection from the patient line stopcock connectors.

Code information: 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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for catheter disconnection from the patient line stopcock connectors.