CODMAN® 824095Recalls & reported problems
Integra Lifesciences Production Corporation · CODMAN® Disposable Split Trocar · Class 2
All models of CODMAN (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780537373), received between Apr 4, 2025 and Apr 4, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00459 A FACILITY REPORTED THAT A CERTAS VALVE (ID 828811PL) WAS PLACED ON (B)(6) 2023, VIA VENTRICULOPERITONEAL (VP) SHUNT. ON (B)(6) 2023, THE PATIENT PRESENTED WITH SHUNT MALFUNCTION SYMPTOMS AND CATHETER FRACTURE WAS DISCOVERED ON SHUNT SERIES. REVISION SURGERY WAS PERFORMED TO RETRIEVE THE CATHETER. THE PATIENT WAS ADMITTED ON (B)(6) 2023, AND WAS DISCHARGED ON (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21773358 ↗MalfunctionApr 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00456. A FACILITY REPORTED THAT A BACTISEAL CATHETER (ID (B)(4) WAS IMPLANTED VIA VENTRICULOPERITONEAL (VP) SHUNT ON (B)(6) 2023. THE DEVICE WAS USED ALONG WITH DISPOSABLE SPLIT TROCAR (ID (B)(4). ON (B)(6) 2023, THE PATIENT PRESENTED WITH SHUNT MALFUNCTION SYMPTOMS AND CATHETER FRACTURE WAS DISCOVERED ON SHUNT SERIES, A REVISION SURGERY WAS DONE. LAPAROSCOPY WAS PERFORMED TO RETRIEVE DISTAL SHUNT CATHETER FRAGMENT ON THE DISTAL CATHETER. THE PATIENT WAS ADMITTED ON (B)(6) 2023 AND WAS DISCHARGED ON (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21773357 ↗
Other Shunt, central nervous system and components devices
- NATUS EDS3 DRAINAGE SYSTEM NT821731CNatus Medical Incorporated · Shunt, Central Nervous System And Components1 recall208 reports
- Exacta™ 46700Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall2 deaths163 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 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 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page