TraumaCath™ INS8420Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780023890), received between Jun 16, 2022 and Jul 2, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Crack; Crack

  A FACILITY REPORTED THAT ON INSERTION OF A NEW EXTERNAL VENTRICULAR DRAINAGE (EVD), THE TRAUMACATH, 35CM (INS8420) WAS NOTED TO HAVE A CRACK IN IT. PATIENT IMPACT WAS UNKNOWN, AND THERE WAS SURGICAL DELAY; HOWEVER, THE DURATION OF THE DELAY IS UNKNOWN. UNFORTUNATELY AFTER FOLLOWING UP WITH THE TEAM AND THE SITE, NO FURTHER INFORMATION IS AVAILABLE FOR THIS CASE AS IT OCCURRED LAST YEAR, AND THE HOSPITAL DOES NOT HAVE ANY NOTES ON THE ISSUE TO REFER TO.

  Patient problems: Insufficient Information

  MAUDE report 22385703 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDWATCH REPORT (MW5109804) WAS RECEIVED ON (B)(6) 2022 WITH THE FOLLOWING INFORMATION: "CALLER CALLED TO REPORT THAT SHE HAS HAD SEVEN (7) REVISIONS WITH HER SHUNT VALVE.. SHE HAD EXPERIENCED INTERNAL LACERATIONS, FROZEN SHOULDER, ADHESIONS, ABDOMINAL WOUNDS THAT WOULD NEVER HEAL, CSF LEAKAGE, HEADACHES AND INCREASED PULSE RATE. SHE COULD FEEL SHARP EDGES FROM THE DEVICE IN HER ABDOMEN. WITH EACH REVISION THE SURGEON WOULD NOTE THAT THE DEVICE IS DEFECTIVE, THE POP OFF WOULD NOT FUNCTION CORRECTLY. WHEN SHE SHOULD HAVE 25 ML OF PRESSURE RELIEF, SHE WOULD GET 3ML. REPORTER STATES THAT SHE ON BEDREST FOR A YEAR AND WAS SO DEPRESSED PRIOR TO HER LAST SURGERY THAT SHE ASKED THE DOCTOR TO LET DIE ON THE TABLE. SHE NO LONGER FEELS SUICIDAL DUE TO COMPLETE REMOVAL OF THE SYSTEM AND STATES THAT HER LIFE HAS IMPROVED, BUT SHE WILL NEVER BE THE SAME." INTEGRA RECEIVED ADDITIONAL/CLARIFYING INFORMATION FROM THE PATIENT VIA TELEPHONE CONVERSATION ON 5/15/2022 AS FOLLOWS: THE INTEGRA PRODUCT IN QUESTION IS TRAUMACATH, 35CM (INS8420) WHICH WAS USED CONCOMITANTLY WITH THE MEDTRONIC SHUNT. PATIENT ADVISED THAT THE INTEGRA CATHETER WAS NOT THE FAULT OF HER INJURIES/REVISION PROCEDURES AND ALLEGED

  Patient problems: Adhesion(s); Cerebrospinal Fluid Leakage; Headache

  MAUDE report 14715554 ↗