Sterile cannulaRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290114063340), received between Jul 23, 2024 and Sep 5, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Missing Information” (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 16, 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.

• MalfunctionSep 5, 2024Missing Information; Missing Information

  DURING A DBS CASE IN MAYO CLINIC HOSPITAL -ROCHESTER, MN A WRONG CANNULA WAS CHOSEN, PLEASE SEE THE HOSPITAL'S PATIENT SAFETY SPECIALIST DESCRIPTION BELOW: WRONG CANNULA WAS OPENED AND PLACED INTO THE BRAIN WHILE PATIENT WAS AWAKE, BUT PATIENT SHOWED NO ADVERSE EFFECTS. IT WAS DISCOVERED BY AN X-RAY TAKEN TO CONFIRM PLACEMENT THAT THE CANNULA HAD GONE TOO DEEP. STAFF WAS UNAWARE THAT THERE WERE TWO TYPES OF CANNULAS BOTH LABELED 15MM TO TARGET AVAILABLE. ONE IS NEWLY ON THE SHELF THAT IS SPECIFICALLY MADE FOR ONE TYPE OF PROCEDURE. IT WAS NOT CLEARLY MARKED THAT THEY WERE DIFFERENT. ON THE RIGHT-HAND SIDE OF THE PRODUCT PACKAGES, THERE IS LENGTH TYPED, BUT IT IS NOT IN THE MAIN LABEL DESCRIPTION. PACKAGES ARE ALMOST IDENTICAL. THIS IS A HUGE SAFETY RISK, AND WE SUGGEST REVISION OF PACKAGING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20144947 ↗
• MalfunctionJul 23, 2024

  WRONG CANNULA WAS OPENED AND PLACED INTO THE BRAIN WHILE PATIENT WAS AWAKE, BUT PATIENT SHOWED NO ADVERSE EFFECTS. IT WAS DISCOVERED BY AN X-RAY TAKEN TO CONFIRM PLACEMENT THAT THE CANNULA HAD GONE TOO DEEP. STAFF WAS UNAWARE THAT THERE WERE TWO TYPES OF CANNULAS BOTH LABELED 15MM TO TARGET AVAILABLE. ONE IS NEWLY ON THE SHELF THAT IS SPECIFICALLY MADE FOR ONE TYPE OF PROCEDURE. IT WAS NOT CLEARLY MARKED THAT THEY WERE DIFFERENT. ON THE RIGHT-HAND SIDE OF THE PRODUCT PACKAGES, THERE IS LENGTH TYPED, BUT IT IS NOT IN THE MAIN LABEL DESCRIPTION. PACKAGES ARE ALMOST IDENTICAL. THIS IS A HUGE SAFETY RISK, AND WE SUGGEST REVISION OF PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804983 ↗