DuetRecalls & reported problems across all models
Medtronic Ps Medical, Inc. · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name at least one Duet model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 134
- Deaths reported
- 1
- Injuries reported
- 12
- Recalls
- 6
We found 16 models of Duet by Medtronic Ps Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 134 adverse event reports in the FDA's MAUDE database, received between Mar 22, 2017 and Jun 16, 2026 — classified as 1 death, 12 injuries, 121 malfunctions.
The most frequently reported specific device problem is “Disconnection” (86 reports).
6 FDA recall records name at least one of these models by its device identifier, 6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Duet recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 22, 2024Open, Classified
Potential for catheter disconnection from the patient line stopcock connectors.
Z-1166-2024 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Jan 22, 2024Open, Classified
Potential for catheter disconnection from the patient line stopcock connectors.
Z-1165-2024 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Jan 22, 2024Open, Classified
Potential for catheter disconnection from the patient line stopcock connectors.
Z-1164-2024 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Jan 22, 2024Open, Classified
Potential for catheter disconnection from the patient line stopcock connectors.
Z-1163-2024 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Jan 22, 2024Open, Classified
Potential for catheter disconnection from the patient line stopcock connectors.
Z-1162-2024 · Root cause: Under Investigation by firm · names 3 of these models · 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 Duet problems
Device problems
- Disconnection86
- Fluid/Blood Leak80
- Break20
- Fracture17
- Device Dislodged or Dislocated5
- Loose or Intermittent Connection5
- Appropriate Device Problem Term/Code Not Available2
- Device Operates Differently Than Expected2
Patient problems
- No Clinical Signs, Symptoms or Conditions110
- No Known Impact Or Consequence To Patient13
- Unspecified Tissue Injury3
- Ambulation or Postural Difficulties2
- Cerebrospinal Fluid Leakage2
- Device Embedded In Tissue or Plaque2
- Insufficient Information2
- Malaise2
Duet models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Duet® 46913Device, monitoring, intracranial pressure1 recall58 reports
- Duet® 46915External cerebrospinal fluid (CSF) diversion2 recalls1 report
- Duet® 46913DEVICE, MONITORING, INTRACRANIAL PRESSURE1 recall1 death15 reports
- Duet® 46914External cerebrospinal fluid (CSF) diversion1 recall15 reports
- Duet® 46913Shunt, central nervous system and components1 recall14 reports
- Duet® 46914DEVICE, MONITORING, INTRACRANIAL PRESSURE1 recall13 reports
- Duet® 46914External cerebrospinal fluid (CSF) diversion1 recall7 reports
- Duet® 46917DEVICE, MONITORING, INTRACRANIAL PRESSURE1 recall5 reports
- Duet® 46916External cerebrospinal fluid (CSF) diversion1 recall4 reports
- Duet® 46915DEVICE, MONITORING, INTRACRANIAL PRESSURE1 recall0 reports
- Duet® 46915Device, monitoring, intracranial pressure1 recall0 reports
- Duet® 46916Shunt, central nervous system and components1 recall0 reports
- Duet® 46917External cerebrospinal fluid (CSF) diversion1 recall0 reports
- Duet® 46916External cerebrospinal fluid (CSF) diversion1 recall0 reports
- Duet® 46917Device, monitoring, intracranial pressure1 recall0 reports
- Duet® 46912Device, monitoring, intracranial pressure2 reports
Recent Duet adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM COLLECTION BAG. IT WAS REPORTED THE SITE ATTEMPTED TO MOVE THE UNIT (BAG AND TUBING) IN ORDER TO COLLECT 10CC PER ORDER, AND WHEN REMOVING, THE BAG BECAME DISCONNECTED FROM THE TUBING CONNECTOR. STERILITY WAS MAINTAINED AND THE BAG WAS REPLACED. NO SERIOUS HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25520584 ↗MalfunctionJul 16, 2025Disconnection; Mechanical Jam; Disconnection; Mechanical Jam
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE HEALTHCARE PROFESSIONAL (HCP) WENT TO CHANGE THE DEVICE'S BAG AS IT WAS 3/4 FULL. WHEN THE HCP WENT TO REMOVE THE BAG FROM LEUR LOCK SYSTEM, THEY WERE UNABLE TO REMOVE THE OLD BAG. THE HCP REQUIRED KELLY CLAMPS TO REMOVE THE OLD BAG FROM THE SYSTEM. WHEN THE HCP WAS USING THE KELLY CLAMPS TO REMOVE THE OLD BAG, THE BAG DISCONNECTED FROM THE LEUR LOCK SYSTEM AND FELL TO GROUND AND DID LEAK MINIMALLY FROM THE TOP OF BAG. HOWEVER, THE LEUR LOCK OF OLD BAG REMAINED IN PLACE EVEN THROUGH THE BAG DISCONNECTION. THE HCP WAS ABLE TO SUCCESSFULLY REMOVE THE BAG AFTER GREAT DIFFICULTY WITH THE KELLY CLAMPS. THE SYSTEM END WAS CLEANED WITH CHLOROHEXIDINE AND THE BAG SPOUT. BOTH WERE ALLOWED TO DRY BEFORE CONNECTING THE NEW DRAINAGE BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22519002 ↗InjuryApr 30, 2025Break; Fracture; Infusion or Flow Problem; Break; Fracture; Infusion or Flow Problem
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PATIENT REQUIRED AN EXTERNAL VENTRICULAR DRAIN (EVD), AND THE DRAIN THAT WAS USED WAS DEFECTIVE CAUSING AN ISSUE WITH THE PATIENT. THE HEALTHCARE PROFESSIONAL (HCP) STATED THEY RECEIVED THE DEVICE FROM AN AFFILIATED HOSPITAL IN WHICH WAS CRACKED. THE PATIENT LOST 100 MILLILITERS OF CEREBROSPINAL FLUID. AS A RESULT, THE PATIENT RECEIVED A SHUNT. THE HCP CONVEYED THE PATIENT WAS DOING OK AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 21936365 ↗MalfunctionApr 22, 2024
RN NOTED THAT EXTERNAL VENTRICULAR DRAINAGE (EVD) TUBING BROKE AND CEREBROSPINAL FLUID WAS FOUND SATURATING LINENS.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 19152246 ↗MalfunctionApr 11, 2024
THE EXTERNAL VENTRICULAR DRAINAGE (EVD) WAS LEAKING AND THE NIPPLE WAS FOUND TO BE CRACKED. REPLACED WITH NEW NIPPLE UNDER STERILE CONDITIONS. POSITIVE CSF CULTURE FOR STREPTOCOCCUS MITIS / ORALIS.
Patient problems: Bacterial Infection
MAUDE report 19087291 ↗MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM (EDMS). IT WAS REPORTED THAT CEREBROSPINAL FLUID (CSF) LEAKAGE WAS NOTED FROM THE STOPCOCK CONNECTED TO THE EDMS. INCREASED LEAKAGE WAS NOTED WHEN THE STOPCOCK WAS CLAMPED TOWARD THE PATIENT OR TOWARD THE CHAMBER. THE DOCTOR WAS NOTIFIED, AND THE EQUIPMENT WAS CHANGED OUT. NO OTHER DRAINAGE NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19046595 ↗MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHEN POURING THE DRAINAGE FLUID, THERE WAS LEAKAGE FOUND FROM THE SCREW PLUG OF THE DRAINAGE BAG. THE DOCTOR WAS NOTIFIED IMMEDIATELY TO CLAMP AND CLOSE THE DRAINAGE TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19044715 ↗MalfunctionMar 7, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHEN CHECKING ON THE PATIENT, WET AREA WAS NOTED ON THE PILLOW BEHIND THE HEAD. THE SYSTEM WAS NOTED TO HAVE BEEN DISCONNECTED AT THE CLEAR PORT PROXIMAL TO THE CATHETER IN THE PATIENT'S HEAD. THE APPROXIMATE AGE OF THE DEVICE WAS 1 DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18858155 ↗MalfunctionMar 6, 2024Disconnection; Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SYSTEM SEPARATED AT THE LUER LOCK AND CONNECTING TUBING LEADING TO A RISK OF INFECTION AND RE-INSERTION. THE APPROXIMATE AGE OF THE DEVICE WAS 1 DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18850219 ↗MalfunctionMar 6, 2024Disconnection; Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SYSTEM SEPARATED AT THE LUER LOCK AND CONNECTING TUBING LEADING TO A RISK OF INFECTION AND RE-INSERTION. THE APPROXIMATE AGE OF THE DEVICE WAS 1 DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18849948 ↗MalfunctionMar 6, 2024Disconnection; Disconnection
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SYSTEM SEPARATED AT THE LUER LOCK AND CONNECTING TUBING LEADING TO A RISK OF INFECTION AND RE-INSERTION. THE APPROXIMATE AGE OF THE DEVICE WAS 1 DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18849815 ↗MalfunctionMar 4, 2024
WHEN CHECKING ON PATIENT, WET AREA NOTED ON PILLOW BEHIND HEAD. EVD WAS NOTED TO HAVE BEEN DISCONNECTED AT CLEAR PORT PROXIMAL TO THE CATHETER IN PATIENT'S HEAD.
Patient problems: Insufficient Information
MAUDE report 18826021 ↗MalfunctionMar 4, 2024
THREE INSTANCES OF EXTERNAL VENTRICULAR DRAINAGE SYSTEMS (EVD) SEPARATING AT THE LUER LOCK AND CONNECTING TUBING LEADING TO A LARGE RISK OF INFECTION AND RE-INSERTION.
Patient problems: Unspecified Infection
MAUDE report 18825982 ↗MalfunctionFeb 19, 2024Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT A SIMILAR EVENT TO THE FOLLOWING OCCURRED AT THE END OF JANUARY: WHILE MONITORING AND DRAINING CEREBROSPINAL FLUID (CSF) WITH THE SYSTEM, THE DOCTOR FOUND THAT THERE WAS A CSF LEAK FROM THE PATIENT LINE. IT WAS NOTED THAT THE LEAK PROBABLY CAME FROM A CONNECTION FAULT FROM THE STOPCOCK ON THE PATIENT LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18730734 ↗MalfunctionFeb 19, 2024Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT WHILE MONITORING AND DRAINING CEREBROSPINAL FLUID (CSF) WITH THE SYSTEM, THE DOCTOR FOUND THAT THERE WAS A CSF LEAK FROM THE PATIENT LINE. IT WAS NOTED THAT THE LEAK PROBABLY CAME FROM A CONNECTION FAULT FROM THE STOPCOCK ON THE PATIENT LINE. THE PRODUCT WAS REPLACED BY ANOTHER MANUFACTURER'S DEVICE. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18730661 ↗
Other Medtronic Ps Medical, Inc. products
All Medtronic Ps Medical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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