CODMAN EDS 3 82-1731CRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886704079873), received between Feb 24, 2022 and Oct 19, 2023 — classified as 1 death, 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, 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

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895142 ↗
• 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 ↗
• 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 ↗