Cannula StandardRecalls & reported problems
Alpha Omega Engineering CO. Ltd. · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290014954694), received between Aug 14, 2018 and Aug 14, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Malposition of Device1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2018Improper or Incorrect Procedure or Method; Malposition of Device
AN INCIDENT WAS REPORTED BY "DEPARTMENT OF NEUROSURGERY, (B)(6) UNIVERSITY" IN (B)(6) (THE CUSTOMER), WHICH USES ALPHA OMEGA ENGINEERING'S (AOE) NEURO OMEGA SYSTEM FOR NAVIGATION DURING NEUROSURGERY FOR PLACEMENT A DBS ELECTRODE. AOE'S CANNULA P/N-STR-007721-10, WITH LENGTH 177 MM, IS NORMALLY USED FOR THIS NEUROSURGERY PROCEDURE. IN THE REPORTED INCIDENT, A LONGER IDENTICAL CANNULA WAS MISTAKENLY USED (P/N- STR-020121-10, WITH LENGTH 201.5 MM), RESULTING A DIPPER INSERTION, BEFORE THE MISTAKE WAS REALIZED BY THE CUSTOMER. THE TWO TYPES OF CANNULAS ARE USED BY THE CUSTOMER'S FOR DIFFERENT HEAD FRAMES. THE LABEL ON THE CANNULA CLEARLY IDENTIFIES THE CANNULA TYPE (BY PART NUMBER, LENGTH AND DIAMETER). NO INJURY MEDICAL INTERVENTION TO THE PATIENT WAS REPORTED BY CUSTOMER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7780725 ↗
Other Electrode, Depth devices
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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