CODMAN EDS 3Recalls & reported problems across all models
Cerenovus, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 1
- Injuries reported
- 8
- Recalls
- 0
We found 6 models of CODMAN EDS 3 by Cerenovus, Inc. in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Dec 29, 2017 and Oct 19, 2023 — classified as 1 death, 8 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Disconnection” (7 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
Reports received per month, all models
Most reported CODMAN EDS 3 problems
Device problems
- Disconnection7
- Leak/Splash6
- Break5
- Fluid/Blood Leak5
- Device Operational Issue4
- Failure to Disconnect2
- No Flow2
- Pressure Problem2
Patient problems
- No Known Impact Or Consequence To Patient13
- Cerebrospinal Fluid Leakage7
- No Consequences Or Impact To Patient7
- No Clinical Signs, Symptoms or Conditions5
- Air Embolism1
- Bacterial Infection1
- Fever1
- Insufficient Information1
CODMAN EDS 3 models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CODMAN EDS 3 82-1731CShunt, central nervous system and components1 death10 reports
- CODMAN EDS 3 82-1731Shunt, central nervous system and components9 reports
- CODMAN EDS 3 82-1730Shunt, central nervous system and components8 reports
- CODMAN EDS 3 82-1738Shunt, central nervous system and components4 reports
- CODMAN EDS 3 82-1735Shunt, central nervous system and components1 report
- CODMAN EDS 3 82-1730CShunt, central nervous system and components1 report
Recent CODMAN EDS 3 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPORTED: "EDS3 SYSTEM WAS BEING USED ON A PATIENT. PATIENT ICP WAS ALSO BEING MONITORED WITH A NON-INTEGRA ICP SENSOR/TRANSDUCER AND GE PATIENT MONITOR." INTEGRA'S ACCOUNT MANAGER WAS CONTACTED BY THE ANAESTHETIC NURSE ON (B)(6) 2023 REGARDING THE ACCURACY OF EDS3C WHEN SET UP FOR ICP MONITORING. THE ACCOUNT MANAGER SAID THEY WOULD SPEAK WITH THE PROFESSIONAL EDUCATION MANAGER AND GET BACK TO THEM. THEN, IN A SECOND CONVERSATION, WHEN RELAYING THE PRODUCT INFORMATION BACK TO THE CUSTOMER, THE NURSE CONFIRMED THERE HAD BEEN A PATIENT DEATH. THE ACCOUNT MANAGER SAID THEY NEED TO REPORT THE INFORMATION. THE NURSE RESPONDED WITH THAT IT WAS VERY LIKELY TO BE ¿HUMAN ERROR AND NOT RELATED TO EDS3C¿. THE ACCOUNT MANAGER REITERATED 3 TIMES THAT THEY WOULD LIKE TO REPORT IT BUT THE NURSE REMAINED RELUCTANT TO GIVE ANY FURTHER DETAILS. ADDITIONAL INFORMATION FROM SALES REPRESENTATIVE. IN ANOTHER CONVERSATION OF THE INTEGRA'S ACCOUNT MANAGER WITH THE NEURO ANUM FOR THEATERS: "HE SAID THAT THE PATIENT HAD NOT HAD AN ICP READING TAKEN IN RECOVERY AND WAS FINALLY DONE ON THE WARD WHEN IT WAS FOUND TO BE HIGH. HE SAID IT WASN¿T PRODUCT RELATED SO WOULDN¿T SHARE ANY FURTHER INFORMATION
Patient problems: Insufficient Information
MAUDE report 17968629 ↗MalfunctionMay 9, 2023Break; Break
InjuryMay 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED AN EDS DRAINAGE SYSTEM (ID 821731C) WAS PLACED TO TREAT PERSISTENT HYDROCEPHALUS POST SUBARACHNOID HEMORRHAGE DUE TO RUPTURED ANEURYSM. EIGHT DAYS AFTER PLACEMENT CSF LEAKAGE WAS NOTED AT THE TAP WHICH THE "PRESSURE HEAD" WAS CONNECTED. THE PATIENT HAD STAPHYLOCOCCAL VENTRICULITIS WITH NEUROLOGICAL DETERIORATION 3 DAYS AFTER DISCOVERING THE CRACK, TREATED WITH ANTIBIOTIC THERAPY ADAPTED TO STAPH EPI (VANCOMYCIN) STARTED ON (B)(6) 2023, RELAYED BY LINEZOLID: TREATMENT FOR 14 DAYS AND CHANGE OF EVD SYSTEM ON (B)(6) 2023. NEGATIVE CSF SAMPLE SINCE (B)(6) 2023, AND APYREXIA ON (B)(6) 2023. NEUROLOGICAL CONSEQUENCES FOR THE PATIENT: PATIENT WAS IN THE AWAKENING PHASE WHEN VENTRICULITIS OCCURRED. THE PATIENT HAD LOSS/ABSENCE OF RESPONSE TO SIMPLE ORDERS/REQUESTS AND SPONTANEOUS OPENING OF THE EYES. OUTCOME OF THE PATIENT: THE PATIENT IS DOING BETTER, SHE AWAKES PROGRESSIVELY. SHE IS STILL IN ICU AND INTUBATED.
Patient problems: Bacterial Infection; Cerebrospinal Fluid Leakage; Fever
MAUDE report 16856734 ↗InjuryMay 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED A EDS DRAINAGE CATHERER (ID 821731C) WAS PLACED ON (B)(6) 2023 FOR THE TREATMENT OF HYDROCEPHALUS FOLLOWING SUBARACHNOID HEMORRHAGE DUE TO RUPTURED CEREBRAL ANEURYSM. 13 DAYS LATER THERE WAS A CSF LEAK THROUGH THE EDS DRAINAGE CATHETER. THE DRAINAGE SYSTEM (821731C) WAS REPLACED, AND THE CATHETER FOR THE EXTERNAL VENTRICULAR DRAINAGE (INS-8420) STAYED IMPLANTED.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 16854484 ↗InjuryNov 4, 2022Break; Break
2 OF 4 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2022-00510, 3013886523-2022-00512, 3013886523-2022-00513. A FACILITY REPORTED BREAKAGE OF THE PLASTIC PART UNDER THE SCREW THREAD OF A EDS DRAINAGE SYSTEM CAUSING CSF LEAKAGE AT THE TAP. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 15735286 ↗InjuryNov 4, 2022Break; Break
3 OF 4 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2022-00510, 3013886523-2022-00511, 3013886523-2022-00513. A FACILITY REPORTED BREAKAGE OF THE PLASTIC PART UNDER THE SCREW THREAD OF A EDS DRAINAGE SYSTEM CAUSING CSF LEAKAGE AT THE TAP. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 15735225 ↗InjuryNov 4, 2022Break; Break
1 OF 4 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2022-00511; 3013886523-2022-00512; 3013886523-2022-00513. A FACILITY REPORTED BREAKAGE OF THE PLASTIC PART UNDER THE SCREW THREAD OF A EDS DRAINAGE SYSTEM CAUSING CSF LEAKAGE AT THE TAP. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 15735011 ↗InjuryJul 20, 2022Disconnection; Disconnection
A FACILITY REPORTED A EDS3 DRAINAGE SYSTEM (ID (B)(6)) DISCONNECTED FROM A LUMBAR DRAIN. LUMBAR DRAIN WAS REMOVED DUE OF DRAIN DISCONNECTION. PATIENT WAS MONITORED AND WAS IN SATISFACTORY CONDITION. NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15065706 ↗InjuryJun 1, 2022Break; Break
A FACILITY REPORTED A BROKEN THREAD BETWEEN COLLECTION BAG AND EDS3 DRAINAGE SYSTEM. THE ISSUE HAPPENED WHEN CHANGING THE COLLECTION BAG AND THE DRAINAGE SYSTEM HAD TO BE REPLACED ON (B)(6) 2022 WHICH TOOK 20 MINUTES AND PATIENT CARE WAS DELAYED 1 HOUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14565870 ↗MalfunctionFeb 24, 2022Leak/Splash; Leak/Splash
A FACILITY REPORTED A EDS DRAINAGE SYSTEM WAS REPLACED DUE TO BROKEN SCREW RESULTING THE SYSTEM TO FALL. CSF LEAKAGE WAS OBSERVED AT THREAD SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13591186 ↗MalfunctionFeb 24, 2022Fluid/Blood Leak; Fluid/Blood Leak
A FACILITY REPORTED CSF LEAKAGE OF A EDS DRAINAGE SYSTEM DUE TO WEAKNESS OF A SCREW THREAD BETWEEN THE COLLECTION BAG AND DRAINAGE SYSTEM. THE DRAINAGE SYSTEM WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13591002 ↗MalfunctionFeb 15, 2019Disconnection; Disconnection
TUBING BECAME DISCONNECTED FROM BURETTE CHAMBER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8345871 ↗MalfunctionFeb 15, 2019Disconnection; Disconnection
STOPCOCK DISCONNECTED FROM TUBING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8345844 ↗MalfunctionFeb 15, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
EDS III LEAKED AT 3-WAY STOP COCK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8345691 ↗MalfunctionFeb 15, 2019Disconnection; Disconnection
EDS III LEAKED AT CONNECTION AND WOULD NOT DRAIN INTO THE COLLECTION BAG.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8345599 ↗
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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