# FDA recall Z-1165-2024

> **Medtronic Neurosurgery** · Class I · device recall initiated 2024-01-22.

## Product

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

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.

## Key facts

- **Recall number:** Z-1165-2024
- **Recalling firm:** Medtronic Neurosurgery
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-22
- **Report date:** 2024-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1165-2024

## Citation

> AI Analytics. FDA recall Z-1165-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1165-2024. Source: US FDA. Licensed CC0.

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