Medtronic Duet External Drainage System Recalled for Catheter Disconnection Risk
Medtronic is recalling 30,711 units of its Duet External Drainage System because of the potential for catheter disconnection from patient line stopcock connectors.
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: FDA Class I recall of a neurological medical device involving potential catheter disconnection. Per the severity rubric, FDA Class I recalls must receive a minimum score of 4, even in the absence of reported illnesses or injuries.
Plain-English summary
Medtronic Neurosurgery is recalling 30,711 units of the Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO. The device is used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume in neurosurgical patients.
The recall addresses a potential for catheter disconnection from the patient line stopcock connectors. Specific affected lot numbers have been identified and are available from the FDA and Medtronic. The recalled devices have been distributed worldwide, including throughout the United States and to numerous international locations.
Healthcare providers using this device should verify whether they have affected units by checking against the identified lot numbers. If affected devices are identified, they should stop use immediately and contact Medtronic Neurosurgery for replacement or additional guidance. Patients who have received treatment with this device should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
- Manufacturer
- Medtronic Neurosurgery
- Hazard
- Affected units
- 30,711
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: 221482527 00613994445360
- 221569956 00763000406004
- 221569957 00763000406004
- 221614450 00613994445360
- 221614451 00613994445360
- 221614452 00613994445360
- 221687764 00763000406004
- 221744157 00763000406004
- 221744547 00763000406004
- 221795478 00613994445360
- 221873430 00763000406004
- 221955228 00763000406004
- 221955229 00763000406004
- 222061753 00763000406004
- 222061754 00763000406004
- 222082061 00613994445360
- 222121358 00613994445360
- 222186493 00613994445360
- 222186494 00613994445360
- 222186495 00613994445360
Distribution
Part of a larger recall action
This product is one of 5 recalled by Medtronic Neurosurgery under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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