Medtronic Neurosurgery: 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.

Agency Publication Date: June 27, 2014

Affected Products

Product: 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.

Lot No. 206923217 207096627 207096630 207187691 207224897 207269986 207466017 207565424 207565425 207659575 207659576 207739874 207875274 207945037 207982847

Product: 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.

Lot No. 206843112 206854300 206875578 206923218 206951123 206962974 206986677 207167084 207246210 207312741 207441171 207466011 207466012 207560684 207632971 207659577 207716835 207716836 207766493 207900255 207945036 207983301 208008802

Product: 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.

Lot No. 206923344 206986678 207096628 207565426 207659574 207945035 207982846 208031201 208055143

Product: 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.

Lot No. 206843114 206854302 206923345 207167085 207246211 207466015 207565607 207716842 207766492 208031202

Product: 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.

Lot No. 208031203

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 68503

Status: Resolved

Manufacturer: Medtronic Neurosurgery

Manufactured In: United States

Units Affected: 5 products (3,026 units; 5,744 units; 760 units; 1,187 units; 35 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Lot No. 206923217 207096627 207096630 207187691 207224897 207269986 207466017 207565424 207565425 207659575 207659576 207739874 207875274 207945037 207982847

Lot No. 206923344 206986678 207096628 207565426 207659574 207945035 207982846 208031201 208055143

Lot No. 206843114 206854302 206923345 207167085 207246211 207466015 207565607 207716842 207766492 208031202

Lot No. 208031203