Integra Essential Shunt Kit NL8504111Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780356127), received between Jun 17, 2025 and Aug 14, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Improper Flow or Infusion” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2025Improper Flow or Infusion; Improper Flow or Infusion

  THIS REPORT IS LINKED TO THE FOLLOWING MFG REPORT NUMBERS: 2648988-2025-00022; 2648988-2025-00036; 2648988-2025-00037. AN INTEGRA AUTHORIZED DISTRIBUTOR REPORTED THE FOLLOWING: "DURING A MEETING AT THE CLINICAL HOSPITAL OF THE MEDICAL UNIVERSITY OF (B)(6), [REDACTED], WHO SPECIALIZES IN SHUNT SYSTEMS AND THE TREATMENT OF HYDROCEPHALUS, PRESENTED US AN UNUSUAL CASE. SHE HAS A 30-YEAR-OLD FEMALE PATIENT WHO UNDERWENT FIVE REPLACEMENTS OF THE ESSENTIAL SHUNT SYSTEM AND WAS REFERRED TO HER WITH A NON-FUNCTIONING SHUNT JUST TWO WEEKS AFTER A REOPERATION. THE REOPERATIONS WERE PERFORMED AT PSK4 HOSPITAL IN (B)(6), AND WHAT IS PARTICULARLY ALARMING IS THAT ALL OF THEM TOOK PLACE WITHIN THE PAST SIX MONTHS. YESTERDAY, DR. [REDACTED] REPLACED THE MALFUNCTIONING ESSENTIAL SHUNT WITH A MIETKE VALVE. CSF EXAMINATION DID NOT REVEAL ANY ABNORMALITIES; PROTEIN LEVELS WERE WITHIN THE NORMAL RANGE. DR. [REDACTED] HANDED OVER THE ESSENTIAL SHUNT VALVE TO US FOR FURTHER EXAMINATION. SHE SUSPECTS IT MAY BE A FAULTY BATCH. ¿ IMPLANTATION DATE: >> (B)(6) 2025. ¿ EXPLANT DATE: >> NO DATA. ¿ REFERENCE AND LOT NUMBER OF THE VALVE? >> NO DATA. ¿ HOW WAS THE VALVE FAILURE DISCOVERED? >> NO DATA. ¿ DID THE PA

  Patient problems: Insufficient Information

  MAUDE report 22806914 ↗
• InjuryAug 14, 2025Improper Flow or Infusion; Improper Flow or Infusion

  THIS REPORT IS LINKED TO THE FOLLOWING MFG REPORT NUMBERS: 2648988-2025-00022. 2648988-2025-00036. 2648988-2025-00038. AN INTEGRA AUTHORIZED DISTRIBUTOR REPORTED THE FOLLOWING: "DURING A MEETING AT THE CLINICAL HOSPITAL OF THE MEDICAL UNIVERSITY OF WARSAW, [REDACTED], WHO SPECIALIZES IN SHUNT SYSTEMS AND THE TREATMENT OF HYDROCEPHALUS, PRESENTED US AN UNUSUAL CASE. SHE HAS A 30-YEAR-OLD FEMALE PATIENT WHO UNDERWENT FIVE REPLACEMENTS OF THE ESSENTIAL SHUNT SYSTEM AND WAS REFERRED TO HER WITH A NON-FUNCTIONING SHUNT JUST TWO WEEKS AFTER A REOPERATION. THE REOPERATIONS WERE PERFORMED AT (B)(6) HOSPITAL IN (B)(6), AND WHAT IS PARTICULARLY ALARMING IS THAT ALL OF THEM TOOK PLACE WITHIN THE PAST SIX MONTHS. YESTERDAY, DR. [REDACTED] REPLACED THE MALFUNCTIONING ESSENTIAL SHUNT WITH A MIETKE VALVE. CSF EXAMINATION DID NOT REVEAL ANY ABNORMALITIES; PROTEIN LEVELS WERE WITHIN THE NORMAL RANGE. DR. [REDACTED] HANDED OVER THE ESSENTIAL SHUNT VALVE TO US FOR FURTHER EXAMINATION. SHE SUSPECTS IT MAY BE A FAULTY BATCH. IMPLANTATION DATE: (B)(6) 2025. EXPLANT DATE: NO DATA. REFERENCE AND LOT NUMBER OF THE VALVE? NO DATA. HOW WAS THE VALVE FAILURE DISCOVERED? NO DATA. DID THE PATIENT EXPERIENCE ANY

  Patient problems: Insufficient Information

  MAUDE report 22806871 ↗
• InjuryAug 14, 2025Improper Flow or Infusion; Improper Flow or Infusion

  THIS REPORT IS LINKED TO THE FOLLOWING MFG REPORT NUMBERS: 2648988-2025-00022. 2648988-2025-00037. 2648988-2025-00038. AN INTEGRA AUTHORIZED DISTRIBUTOR REPORTED THE FOLLOWING: "DURING A MEETING AT THE (B)(6) HOSPITAL OF THE (B)(6)], WHO SPECIALIZES IN SHUNT SYSTEMS AND THE TREATMENT OF HYDROCEPHALUS, PRESENTED US AN UNUSUAL CASE. SHE HAS A 30-YEAR-OLD FEMALE PATIENT WHO UNDERWENT FIVE REPLACEMENTS OF THE ESSENTIAL SHUNT SYSTEM AND WAS REFERRED TO HER WITH A NON-FUNCTIONING SHUNT JUST TWO WEEKS AFTER A REOPERATION. THE REOPERATIONS WERE PERFORMED AT (B)(6) HOSPITAL IN (B)(6), AND WHAT IS PARTICULARLY ALARMING IS THAT ALL OF THEM TOOK PLACE WITHIN THE PAST SIX MONTHS. YESTERDAY, DR. (B)(6) REPLACED THE MALFUNCTIONING ESSENTIAL SHUNT WITH A MIETKE VALVE. CSF EXAMINATION DID NOT REVEAL ANY ABNORMALITIES; PROTEIN LEVELS WERE WITHIN THE NORMAL RANGE. DR. (B)(6) HANDED OVER THE ESSENTIAL SHUNT VALVE TO US FOR FURTHER EXAMINATION. SHE SUSPECTS IT MAY BE A FAULTY BATCH. ¿ IMPLANTATION DATE: (B)(6) 2023, ¿ EXPLANT DATE: NO DATA. ¿ REFERENCE AND LOT NUMBER OF THE VALVE? NO DATA. ¿ HOW WAS THE VALVE FAILURE DISCOVERED? NO DATA. ¿ DID THE PATIENT EXPERIENCE ANY SIGNS AND SYMPTOMS DUE TO VALVE

  Patient problems: Insufficient Information

  MAUDE report 22806508 ↗
• InjuryJun 17, 2025Improper Flow or Infusion; Improper Flow or Infusion

  AN INTEGRA AUTHORIZED DISTRIBUTOR REPORTED THE FOLLOWING: "DURING A MEETING AT THE CLINICAL HOSPITAL OF THE MEDICAL UNIVERSITY OF (B)(6), [REDACTED], WHO SPECIALIZES IN SHUNT SYSTEMS AND THE TREATMENT OF HYDROCEPHALUS, PRESENTED US AN UNUSUAL CASE. SHE HAS A 30-YEAR-OLD FEMALE PATIENT WHO UNDERWENT FIVE REPLACEMENTS OF THE ESSENTIAL SHUNT SYSTEM AND WAS REFERRED TO HER WITH A NON-FUNCTIONING SHUNT JUST TWO WEEKS AFTER A REOPERATION. THE REOPERATIONS WERE PERFORMED AT (B)(6) HOSPITAL IN (B)(6), AND WHAT IS PARTICULARLY ALARMING IS THAT ALL OF THEM TOOK PLACE WITHIN THE PAST SIX MONTHS. YESTERDAY, DR. [REDACTED] REPLACED THE MALFUNCTIONING ESSENTIAL SHUNT WITH A MIETKE VALVE. CSF EXAMINATION DID NOT REVEAL ANY ABNORMALITIES; PROTEIN LEVELS WERE WITHIN THE NORMAL RANGE. DR. [REDACTED] HANDED OVER THE ESSENTIAL SHUNT VALVE TO US FOR FURTHER EXAMINATION. SHE SUSPECTS IT MAY BE A FAULTY BATCH."

  Patient problems: Insufficient Information

  MAUDE report 22235102 ↗