Device recall: Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow
FDA enforcement event 68503 is a device recall by an individual recalling firm (name withheld) of Goleta, CA, initiated 9 Jun 2014 and classified Class I, with 5 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 5% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 14 Jan 2015. Initiation: voluntary: firm initiated.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Individual recalling firm (name withheld), Goleta, CA. FDA names an individual as the recalling firm; this site does not publish people's names.
Reason for recall
"Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock."
Distribution
"Worldwide Distribution -- USA, Australia, Belgium, Canada, Croatia, Cyprus, Denmark, Egypt, Finland, France, Greece, Iran, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Puerto Rico, Romania,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1920-2014 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region. | 3,026 units | Class I | Terminated | 9 Jul 2014 |
| Z-1921-2014 | Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region. | 5,744 units | Class I | Terminated | 9 Jul 2014 |
| Z-1922-2014 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region. | 760 units | Class I | Terminated | 9 Jul 2014 |
| Z-1923-2014 | Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region. | 1,187 units | Class I | Terminated | 9 Jul 2014 |
| Z-1924-2014 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region. | 35 units | Class I | Terminated | 9 Jul 2014 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution -- USA, Australia, Belgium, Canada, Croatia, Cyprus, Denmark, Egypt, Finland, France, Greece, Iran, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Puerto Rico, Romania,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Jan 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.