Medtronic Duet External Drainage System Recalled for Catheter Disconnection Risk
Medtronic is recalling its Duet External Drainage and Monitoring System due to potential catheter disconnection from patient line stopcock connectors. This device is used to drain cerebrospinal fluid and reduce intracranial pressure.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is classified as an FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls never score below Severe (4), making this a Severe-level recall despite no explicit reports of injury or death.
Plain-English summary
Medtronic Neurosurgery is recalling the Duet External Drainage and Monitoring System, SmartSite, Injection Sites (model REF 46914). This medical device is used to drain cerebrospinal fluid (CSF) and reduce intracranial pressure.
The recall is due to a potential for catheter disconnection from the patient line stopcock connectors. Approximately 32,404 units have been distributed worldwide, including across the United States and over 40 countries internationally.
Healthcare providers with affected devices should discontinue use and contact Medtronic for guidance. The affected product is identified by specific lot numbers documented in the FDA recall notice.
The recalled product
- Product
- Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
- Manufacturer
- Medtronic Neurosurgery
- Hazard
- catheter-disconnection
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Number/GTIN: 221482529 00763000395971
- 221520718 00763000395971
- 221648854 00763000395971
- 221687765 00763000395971
- 221744158 00763000395971
- 221744549 00763000395971
- 221795479 00613994445377
- 221827827 00613994445377
- 221827828 00613994445377
- 221873427 00763000395971
- 221873428 00763000395971
- 221915124 00763000395971
- 221915125 00763000395971
- 221916163 00613994445377
- 221916164 00763000395971
- 221955230 00763000395971
- 221955231 00763000395971
- 222015665 00613994445377
- 222061755 00613994445377
- 222204094 00613994445377
Distribution
Distributed nationwide across the United States.
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