Exacta™ 27666Recalls & reported problems
Medtronic Ps Medical, Inc. · EDM 27666 EXCTA W GLUE STPCK GR PT LN · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Medtronic Exacta is a device used to monitor intracranial pressure and drain cerebrospinal fluid. Most of the 124 reports describe fluid leaking from the system, and some describe cracks near the stopcock. The reports include no deaths and no injuries. There is 1 open recall, from November 2024, over cracks and leaks at the drainage system's stopcocks.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 124
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 00763000333515), received between Jul 19, 2023 and Dec 9, 2024 — classified as 124 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (121 reports).
1 FDA recall record name this device's identifier, 1 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Nov 1, 2024Open, Classified
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Z-0662-2025 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak121
- Fracture6
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions124
Recent adverse event reports
The 25 most recent of 124 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DRAINAGE SYSTEM WAS FRACTURING; SPECIFICALLY, THE PORTION NEAR THE STOPCOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20881813 ↗MalfunctionDec 9, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE DRAINAGE SYSTEM WAS FR ACTURING; SPECIFICALLY, THE PORTION NEAR THE STOPCOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20881000 ↗MalfunctionSep 5, 2024Break; Fracture; Break; Fracture
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SMARTSITE INJECTION SITE ON THE DRAINAGE SYSTEM WHERE CEREBROSPINAL FLUID (CSF) SAMPLE WAS EXTRACTED WAS PUSHED IN. THE SYSTEM USED A BAXTER INTERLINK NEEDLELESS INJECTION SITE AND DID NOT HAVE A SMARTSITE INJECTION SITE. THERE WAS NO INFORMATION PROVIDED REGARDING A SYRINGE USED FOR OBTAINING THE SAMPLE AND IF IT WAS APPROPRIATE FOR THE SYSTEM. THE SYSTEM WAS STILL IN USE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20145358 ↗MalfunctionFeb 7, 2024Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THERE WAS A LEAK AT A CONNECTION POINT. THE DEVICE WAS SWITCHED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18658400 ↗MalfunctionJan 11, 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 DRAINAGE SYSTEM (BURETROL) WAS LEAKING CEREBROSPINAL FLUID (CSF) ON THE THREE WAY STOPCOCK. A NEW DRAIN WAS PLACED, AND THE SITE THOUGHT THERE WAS A SLIGHT CRACK IN THE STOPCOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18491567 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18242934 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18242686 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18242675 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18242670 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18242655 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18242082 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18241998 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18241518 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18241361 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18241353 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18241166 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18241000 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18240882 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18240675 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18240530 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18240333 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18240262 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18239583 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18239552 ↗MalfunctionNov 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THE DEVICE WAS DEFECTIVE/DAMAGED DUE TO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18239214 ↗
Other Device, monitoring, intracranial pressure devices
- 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
- CODMAN® MICROSENSOR® 826653Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure68 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 · each recall links to the FDA recall notice
- 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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