Agency classClass IOur severity:Severe FDA (Devices)·Z-1163-2024·Announced 2024-03-06

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.

The agency’s classification

FDA (Devices): Class I

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Category: Medical Device — Neurosurgical Drainage
Hazard: catheter-disconnection
Affected units: 32,404

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.

The notice also names 50 states specifically:

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.

See all 5 products in this recall →

Same manufacturer · Medtronic Neurosurgery

See all →

High
Medtronic Neurosurgery Recalls Ventriculostomy Kit Due to High Endotoxin Levels
FDA (Devices) · 2026-07-29
Severe
Exacta External Drainage System Stopcocks May Leak or Crack
FDA (Devices) · 2024-12-25
Severe
Medtronic Becker Neurosurgical Drainage Systems Recalled for Cracked and Leaking Stopcocks
FDA (Devices) · 2024-12-25
Severe
Medtronic Duet Catheter System Recalled for Potential Disconnection Risk
FDA (Devices) · 2024-03-06
Severe
Medtronic Duet Ventricular Catheter Recalled for Disconnection Risk
FDA (Devices) · 2024-03-06

Same hazard · catheter disconnection