CODMAN MICROSENSORRecalls & reported problems across all models
Cerenovus, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 4 models of CODMAN MICROSENSOR by Cerenovus, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Jul 23, 2018 and Sep 12, 2023 — classified as 8 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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. 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
Most reported CODMAN MICROSENSOR problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings4
- Connection Problem3
- Adverse Event Without Identified Device or Use Problem2
- Fluid/Blood Leak2
- No Device Output2
- Break1
- Defective Device1
- Device Damaged Prior to Receipt by User1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Known Impact Or Consequence To Patient6
- Cerebrospinal Fluid Leakage3
- Failure of Implant1
- Foreign Body In Patient1
- Hydrocephalus1
- Insufficient Information1
- Unspecified Infection1
CODMAN MICROSENSOR models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CODMAN MICROSENSOR 82-6631DEVICE, MONITORING, INTRACRANIAL PRESSURE14 reports
- CODMAN MICROSENSOR 82-6638DEVICE, MONITORING, INTRACRANIAL PRESSURE6 reports
- CODMAN MICROSENSOR 82-6653DEVICE, MONITORING, INTRACRANIAL PRESSURE4 reports
- CODMAN MICROSENSOR 82-6633DEVICE, MONITORING, INTRACRANIAL PRESSURE3 reports
Recent CODMAN MICROSENSOR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2023Obstruction of Flow; Obstruction of Flow
MalfunctionDec 28, 2022Leak/Splash; Leak/Splash
MalfunctionNov 28, 2022No Device Output; No Device Output
InjuryNov 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A FACILITY REPORTED THAT A MICROSENSOR KIT W/ SKULL BOLT (ID 826638) WAS IMPLANTED ON (B)(6) 2022. AFTER INSTALLING THE SENSOR, THE MONITOR DISPLAYED "-99", MAKING IT IMPOSSIBLE TO MEASURE ACCURATELY. THE MICROSENSOR WAS REMOVED, AND ANOTHER PRODUCT WAS USED AND COMPLETED. IT IS UNKNOWN WHICH MONITOR AND CABLE WERE USED. IT IS UNKNOWN IF THE EVENT LEAD TO AN INCREASE IN SURGERY TIME; HOWEVER, NO PATIENT INJURY OR DEATH OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15858614 ↗InjuryJul 13, 2022Failure to Read Input Signal; Failure to Read Input Signal
A FACILITY REPORTED A NEUROMONITOR BASIC KIT (ID 826631) WAS PLACED ON (B)(6) 2022. AFTER THE PATIENT WAS SENT BACK TO WARD THE MICROSENSOR COULD NOT SHOW A NORMAL READINGS. THEY CHANGED WITH A NEW ICP MONITOR (ID 826635) AND NEW CABLE HOWEVER, THE MICROSENSOR STILL COULD NOT SHOW NORMAL READING WITH P-0 ON THE MONITOR AND COULD NOT ENTER INTO THE NEXT STEP. THEREFORE, THE MICROSENSOR WAS REMOVED ON (B)(6) 2022 AND MONITORING WAS STOPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15001104 ↗MalfunctionJun 21, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
A FACILITY REPORTED A BOX OF A NEUROMONITOR BASIC KIT (ID 826631) WAS CRUSHED BEFORE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO SURGICAL DELAY AND ADVERSE CONSEQUENCES TO THE PATIENT WERE OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14755503 ↗InjuryJun 21, 2022Break; Break
A PHYSICIAN REPORTED THE TIP OF A MICROSENSOR (ID 826631) WAS CAUGHT BETWEEN THE SPACE OF THE AUTOLOGOUS BONE AND THE FLAP SEEMED TO BE NARROW, LEAVING ONLY THE TIP TRANSECTED INSIDE THE BODY. SENSOR WAS REMOVED AND THE TIP WAS STILL INSIDE THE BODY. IT IS UNKNOWN IF AN X-RAY WAS TAKEN OR WHAT ACTION WAS IMPLEMENTED. PATIENT CONDITION IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 14755007 ↗MalfunctionMay 7, 2022Failure to Zero; Failure to Zero
A FACILITY REPORTED THAT THE MICROSENSOR (ID 826633) COULD NOT BE ZEROED BY THE ICP MONITOR DURING THE PROCEDURE. THE PHYSICIAN REPLACED WITH ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY OR ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14319054 ↗MalfunctionMar 3, 2022Low Readings; Low Readings
A FACILITY REPORTED A MICROSENSOR WAS READING NEGATIVE VALUES AFTER BEING IMPLANTED FOR SOME TIME. NO PATIENT INJURY OR CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13660954 ↗MalfunctionFeb 16, 2022Connection Problem; Connection Problem
A PHYSICIAN REPORTED THAT WHEN THE OPERATOR OPENED THE MICROSENSOR ((B)(4)) AND CONNECTED IT TO THE MAIN UNIT DURING THE SURGERY, IT WAS NOT RECOGNIZED. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. THE ISSUE WAS DETECTED BEFORE THE IMPLANTATION SITE CLOSURE. NO SURGICAL DELAY OR ADVERSE CONSEQUENCES TO THE PATIENT WERE OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13542728 ↗MalfunctionFeb 10, 2022Device Damaged Prior to Use; Device Damaged Prior to Use
A FACILITY REPORTED A MICROSENSOR ((B)(4)) WITH ASEPTIC PACKING DAMAGED. THE EVENT OCCURRED DURING THE PROCEDURE WHILE THE PHYSICIAN WAS UNPACKING THE OUTER PACKAGE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. THERE WAS NO DELAY AND NO PATIENT INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13508244 ↗MalfunctionFeb 8, 2022Connection Problem; Connection Problem
A FACILITY REPORTED THE ICP MONITOR COULD NOT DETECT THE MICROSENSOR AFTER BEING IMPLANTED; BEFORE IMPLANTATION SITE CLOSURE. THE SURGEON CHANGED WITH A NEW MICROSENSOR. THE EVENT LED TO 10 MINUTES SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13485362 ↗InjuryJan 26, 2022Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A MICROSENSOR (ID 826653) WAS IMPLANTED ON (B)(6) 2021 DURING AN EMERGENCY PROCEDURE. AFTER THE PROCEDURE, THE NURSE FOUND THAT THE MICROSENSOR WAS LEAKING A MINIMAL CEREBROSPINAL FLUID (CSF). THEREFORE, THE MICROSENSOR WAS RETRIEVED IN ADVANCE AND WAS NOT REPLACED.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 13358821 ↗InjuryJan 11, 2022No Device Output; No Device Output
A FACILITY REPORTED A MICROSENSOR WAS IMPLANTED ON (B)(6) 2021, THREE DAYS LATER IT COULD NOT BE DETECTED AND WAS EXPLANTED ON (B)(6) 2021. PATIENT IS IN STABLE CONDITION.
Patient problems: Failure of Implant
MAUDE report 13228993 ↗MalfunctionDec 16, 2021Connection Problem; Connection Problem
Other Cerenovus, Inc. products
- GALAXY G358 models · 1,386 reports · 1 recall
- CODMAN41 models · 107 reports · 22 recalls
- MICRUSFRAME47 models · 298 reports
- DELTAFILL29 models · 294 reports
- CEREPAK FREEFORM60 models · 166 reports · 1 recall
- CEREBASE3 models · 143 reports · 1 recall
- DELTAXSFT13 models · 130 reports
- CEREPAK UNIFORM58 models · 33 reports · 1 recall
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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