Medtronic recalls Duet External Drainage System (SmartSite) with potential catheter disconnection from patient line stopcock connectors. Affected units have specific lot numbers. Contact Medtronic for details.
Potential for catheter disconnection from the patient line stopcock connectors.
Medtronic is recalling its Duet External Drainage and Monitoring System (SmartSite) due to a potential risk of catheter disconnection from the patient line stopcock connectors. This could lead to improper drainage of cerebrospinal fluid and affect treatment for intracranial pressure.
The device has a potential for catheter disconnection from the patient line stopcock connectors. This could cause improper drainage of cerebrospinal fluid, leading to complications such as increased intracranial pressure or infection.
Patients using this medical device for cerebrospinal fluid drainage are most at risk. The device is prescribed by a doctor and used in specific medical conditions.
Check for lot numbers: 221482529, 221520718, 221648854, 221687765, 221744158, 221744549, 221795479, 221827827, 221827828, 221873427, 221873428, 221915124, 221915125, 221916163, 221916164, 221955230, 221955231, 222015665, 222061755, 222204094, 222345104, 222345105, 212346067, 222393929, 222393930, 222530273, 222543362, 222543363, 222580924, 222970856, 222970857, 222970858, 222999295, 222999296, 223070846, 223130156, 223165960, 223165961, 223165962, 223251949, 223580360, 223620063, 223621055, 223659559, 223659560, 223698571, 223734521, 223734522, 223778509, 223999041, 224032597, 224173197, 224342656, 224387139, 224852792, 224852793, 224852794, 224877792, 224878534, 224878535, 224918537, 224949833, 224990656, 224990658, 224990659, 224990661, 224990664, 224990665, 224990851, 224990869, 224990887, 224990888, 225035347, 225234319, 225279761, 225422433, 225468089, 225500028, 225558568, 225587871, 225587872, 225587873, 225587874, 225749839, 225749840, 226111272, 226242266, 226242267, 226242268, 226242269, 226288881, 226288882, 226335063, 226335064, 226335065, 226366037, 226420630, 226420631, 226420632, 226490978, 226490979, 226517897, 226517898, 226567488, 226567489, 226567490, 226567492, 226616244, 226616246, 226756270, 226756271, 226756272, 226810274, 226899370, 226899372, 226951461, 226951462, 226951463, 226951464, 227006497, 227007687, 227136770, 227188107, 227289116, 227289117, 227307929, 227387373
Look for the lot number on the device packaging or label. Affected units have specific lot numbers listed in the recall.
It is used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
Check the lot number on your device packaging or label. Affected units have specific lot numbers listed in the recall.
Contact Medtronic directly for instructions on how to handle the device. The recall does not specify a remedy.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1163-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1163-2024 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
