Exacta™ 46700 (UDI 00673978229171)Recalls & reported problems
Medtronic Ps Medical, Inc. · SYSTEM 46700 EXACTA DISP. DRAINAGE · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00673978229171), received between Feb 7, 2017 and Feb 9, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Fluid/Blood Leak1
- Fracture1
- Leak/Splash1
- Mechanical Jam1
- Occlusion Within Device1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE PHYSICIAN WAS CHECKING ON THE DEVICE AND NOTICED LEAKAGE FROM THE DISTAL STOPCOCK ON THE PATIENT LINE FURTHEST STOPCOCK FROM THE PATIENT WHEN THE KNOB WAS TURNED TO THE OFF POSITION IN THAT DIRECTION. IT WAS STATED THAT THE RED CAP ON THAT PORT WAS DEFORMED. THE DEVICE WAS REPLACED WITH A NEW ONE. HOWEVER, THE NEW DEVICE EXPERIENCED THE SAME LEAKAGE FROM THE SAME STOPCOCK. THERE WAS NO MENTION OF THE CONDITION OF THE THE RED CAP ON THAT DEVICE. IT WAS ATTEMPTED TO REPRODUCE THE LEAKAGE ON THE NEW DEVICE BY SYRINGE-INJECTING WATER THROUGH THE LINES, HOWEVER, IT COULD NOT BE REPRODUCED. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18675753 ↗MalfunctionMar 24, 2017Mechanical Jam; Mechanical Jam
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING THE SURGERY DUE TO A RIGHT JAW CEREBRAL HEMORRHAGE ON (B)(6) 2017, IT WAS FOUND THE STOPCOCK WAS LOCKING AND THE VALVE COULDN'T BE TURNED. ACCORDING TO THE REPORT, THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. REPORTEDLY, THE PATIENT WAS WELL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6433732 ↗MalfunctionFeb 7, 2017Leak/Splash; Occlusion Within Device; Leak/Splash; Occlusion Within Device
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT UNDERWENT SURGERY DUE TO A SUBDURAL HEMORRHAGE. ACCORDING TO THE REPORT, THE LUER CONNECTOR OF THE STOPCOCK LEAKED INTRA-OPERATIVELY. IT WAS STATED THAT FLUID WOULD NOT FLOW OUT AND IT WAS SUSPECTED THE DEVICE WAS BLOCKED. REPORTEDLY, THE DEVICE WAS REPLACED AND THE PATIENT WAS WELL AFTER SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6309733 ↗
Other DEVICE, MONITORING, INTRACRANIAL PRESSURE devices
- Exacta™ 27666Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall124 reports
- Exacta™ 46705Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall117 reports
- CereLink™ 826850Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure1 recall2 deaths112 reports
- Duet® 46913Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall58 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page