Perifix® 333514Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964179907), received between Aug 8, 2022 and Jun 3, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 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.

• MalfunctionJun 3, 2025Break; Break

  PER MEDWATCH NUMBER (B)(4): DESCRIBE EVENT OR PROBLEM: THE CATHETER SHEARED WHILE BEING REMOVED FROM THE PATIENT. THE WIRE COIL SEPARATED FROM THE PLASTIC SHEATH. A PORTION OF THE PLASTIC SHEATH APPEARS TO HAVE REMAINED INSIDE THE PATIENT. THE PLASTIC SHEATH WAS UNABLE TO BE LOCATED ON CT OR MRI. THE MANUFACTURER HAS INFORMED US THAT THE PLASTIC SHEATH IS RADIO TRANSLUCENT, WHILE THE WIRE COIL IS RADIOPAQUE. THIS IS LIKELY WHY WE WERE UNABLE TO VISUALIZE THE PLASTIC SHEATH WITH IMAGING (THE WIRE COIL SEPARATED FROM THE PLASTIC SHEATH, SO THE WIRE COIL WAS FULLY REMOVED FROM THE PATIENT). THE PRODUCT SAFETY CONCERN IN THIS CASE IS THAT THE PLASTIC SHEATH IS NOT RADIOPAQUE. MAKING THE PLASTIC SHEATH RADIOPAQUE WOULD ALLOW FOR IT TO BE LOCATED IN SITUATIONS SUCH AS THESE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22131706 ↗
• MalfunctionAug 8, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT: "CATHETER PUSHED IN HOWEVER RESISTANCE MET. I ATTEMPTED TO PULL CATHETER OUT, HOWEVER I BEGAN TO SEE THE SPRINGROUND COIL AND NOT THE FULL SURROUNDING PLASTIC CATHETER. I BELIEVE I THEN REMOVED BOTH THE EPIDURAL NEEDLE AND CATHETER AND FOUND THE PLASTIC CATHETER THAT REMAINED WAS MISSING A LITTLE PAST THE 5 CM MARKING. THE INNER SPRINGROUND COIL SEEMED TO BE FULLY REMOVED. I HAD TO CALL SPINE SURGERY TO COME IN FOR A CONSULT AS NOW THERE IS POTENTIAL 5 CM OF PLASTIC CATHETER THAT REMAINS IN HER BACK OF UNKNOWN LOCATION AS CATHETER BROKE. PATIENT IS PENDING A LOWER SPINE X RAY AND REASSESSMENT BY SPINE SURGERY. "

  Patient problems: Foreign Body In Patient

  MAUDE report 15189122 ↗