Duet® 46915 (UDI 00763000624781)Recalls & reported problems
Medtronic Ps Medical, Inc. · EDMS DUET 46915 INTERLINK W VCATH · Class 2
All models of Duet (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000624781), received between Jul 17, 2023 and Jul 17, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Complete Blockage” (1 report).
2 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Jan 22, 2024Open, Classified
Potential for catheter disconnection from the patient line stopcock connectors.
Z-1164-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 28, 2023Open, Classified
Product labeling contains incorrect expiration date
Z-2412-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- Complete Blockage1
Patient problems
- Intracranial Hemorrhage1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2023Complete Blockage; Complete Blockage
ADDITIONAL INFORMATION WAS RECEIVED. UPON OF IMMEDIATELY FINDING IT THERE IS WAS NO CLINICAL CHANGE, HOWEVER 2 HOURS LATER THE PATIENT DEVELOPED SYMPTOMS AND A BRAIN BLEED WAS FOUND. THE EVD DRAIN SYSTEM (DUET) WAS EXCHANGED UPON DISCOVERY
Patient problems: Intracranial Hemorrhage; No Clinical Signs, Symptoms or Conditions
MAUDE report 17333093 ↗
Other External cerebrospinal fluid (CSF) diversion devices
- Duet® 46914Medtronic Ps Medical, Inc. · External cerebrospinal fluid (CSF) diversion1 recall15 reports
- Duet® 46914Medtronic Ps Medical, Inc. · External cerebrospinal fluid (CSF) diversion1 recall7 reports
- Duet® 46916Medtronic Ps Medical, Inc. · External cerebrospinal fluid (CSF) diversion1 recall4 reports
- Duet® 46916Medtronic Ps Medical, Inc. · External cerebrospinal fluid (CSF) diversion1 recall0 reports
- Duet® 46917Medtronic Ps Medical, Inc. · External cerebrospinal fluid (CSF) diversion1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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