Duet® 46912Recalls & reported problems
Medtronic Ps Medical, Inc. · BAG 46912 DRAINAGE DEHP-FREE 10PK · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000431273), received between Jul 16, 2025 and Jun 16, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Disconnection” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Disconnection2
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, 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 ↗
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- Becker® 26040Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall46 reports
- CereLink™ 826851Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure96 reports
- Becker® 46129Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall29 reports
- Codman Microsensor® 826631Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure75 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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