Cannula TaperedRecalls & reported problems
Alpha Omega Engineering CO. Ltd. · Class 2 · Implant
- 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 07290014954731), received between Mar 1, 2018 and Mar 1, 2018 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 1, 2018Adverse Event Without Identified Device or Use Problem
ALPHA OMEGA'S DISPOSABLE STERILE CANNULA FOR NEUROSURGERY, MODEL: TAPERED CANNULA (PN STR-000076-10) WAS USED DURING A ROUTINE PLACEMENT OF A DBS ELECTRODE NEUROSURGERY PROCEDURE. FOLLOWING THE NEUROSURGERY, THE USER COMPLAINED THAT HE NOTICED UNUSUAL HEMORRHAGE WHICH HE SUSPECTS THAT WAS CAUSED BY THE USE OF ALPHA OMEGA'S DISPOSABLE STERILE CANNULA. NO OTHER ADVERSE NEUROSURGERY OUTCOMES WERE REPORTED. NO REMEDIAL ACTION WAS REPORTED BY THE HEALTHCARE FACILITY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 7306330 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.