CLASS I ONGOING Device recall · Reported 6 Mar 2024 · FDA Enforcement Report
Medtronic Duet External Drainage and Monitoring System recalled
Medtronic Neurosurgery is recalling Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, distributed nationwide in the US. The recall was initiated on 22 Jan 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1165-2024
- FDA event ID
- 93919
- Recalling firm
- Medtronic Neurosurgery, Irvine, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 22 Jan 2024
- FDA classified
- 27 Feb 2024
- Reported
- 6 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 22 Jan 2024 | Recall initiated by company | |
| 27 Feb 2024 | Classified by FDA | +36 days |
| 6 Mar 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for catheter disconnection from the patient line stopcock connectors.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Is Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites recalled?
Yes. Medtronic Neurosurgery recalled Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites on 22 Jan 2024. The recall is Class I and its status is Ongoing. Recall number Z-1165-2024.
Why was it recalled?
Potential for catheter disconnection from the patient line stopcock connectors.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtronic Neurosurgery
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