Perifix® 332081Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04046964177262), received between Mar 28, 2017 and Nov 11, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Break; Break

  AS REPORTED VIA MEDWATCH NUMBER MW5176732: DESCRIBE EVENT OR PROBLEM: DURING AN EPIDURAL PLACEMENT- PRACTITIONER PULLED OUT THE TUOHY NEEDLE ATTEMPTING TO LEAVE THE CATHETER IN PLACE BUT NOTICED THAT THE CATHETER PULLED OUT WITH THE TUOHY. UPON EXAMINING THE CATHETER CLOSELY, IT WAS NOTICED THAT THE TIP WAS MISSING. THE PROCEDURE WAS ABORTED AT THAT POINT. MEASURED THE MISSING PORTION OF THE CATHETER WHICH I APPROXIMATE TO BE 4-4.5CM.

  Patient problems: Foreign Body In Patient

  MAUDE report 23526848 ↗
• MalfunctionOct 24, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: CATHETER TIP BROKE OFF. PATIENT RECEIVED AN EPIDURAL FOR DELIVERY. EPIDURAL WAS REMOVED PER PROTOCOL. UPON REMOVAL, IT WAS NOTICED THAT THE BLUE TIP WAS NOT INTACT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999067 ↗
• MalfunctionAug 15, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: WHEN CUSTOMER OPENED THE TRAY THERE WAS MOISTURE ALL OVER EVERYTHING AND ALL THE METAL WAS RUSTED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548509 ↗
• MalfunctionAug 11, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: TIP OF BLUE SQ (BELIEVED TO BE 25G) BROKEN DURING ATTEMPTED REMOVAL. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17511242 ↗
• MalfunctionJun 20, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: 1 SMALL GLASS PARTICLE OBSERVED IN THE LOR SYRINGE AFTER THE DEVICE WAS FOUND TO BE DIFFICULT TO USE. THEY COULD NOT PULL THE PLUNGER BACK. THERE IS NO SIGNS OF BROKEN OR DAMAGED SYRINGE, JUST A PARTICLE INSIDE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14743442 ↗
• MalfunctionApr 19, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: END USER REPORTS THAT DURING AN EPIDURAL PLACEMENT, CATHETER FAILED TO THREAD AFTER 5-6CM; WHEN RETRACTING CATHETER AND NEEDLE, DISTAL BLUE TIP OF CATHETER NOTED TO SHEER UNDER TENSION LEAVING BEHIND RETAINED CATHETER FRAGMENTS. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14140372 ↗
• MalfunctionJan 5, 2022Break; Break

  PER MEDWATCH FORM IT WAS REPORTED, "NEEDLE WAS INSERTED FOR EPIDURAL PLACEMENT. WHEN ADVANCING CATHETER THROUGH THE NEEDLE, IT WOULD NOT THREAD: WHEN ATTEMPTING TO WITHDRAW THE EPIDURAL CATHETER, THE TIP OF CATHETER SHEARED OFF AND WAS LEFT IN THE PATIENT. THE PATIENT REQUESTED A CT AFTER THE SPINAL X-RAY DIDN'T SHOW ANYTHING AND IT WAS RECOMMENDED BY NEUROSURGERY TO LET IT STAY THERE UNLESS IT CAUSES ANY FURTHER ISSUES."

  Patient problems: Foreign Body In Patient

  MAUDE report 13173005 ↗
• MalfunctionDec 9, 2019Break; Break

  AS REPORTED BY THE USER FACILITY: REPORTED PROBLEM: END USER STATED THAT THERE WAS A LABORING PATIENT WHO HAD AN EPIDURAL CATHETER IN PLACE WITHOUT COMPLICATION. DURING DELIVERY THE CATHETER SNAPPED OFF AT THE YELLOW CATHETER HUB. THE CATHETER REMAINED IN PATIENT AND WAS THEN REMOVED WITH TIP INTACT. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9438899 ↗
• InjuryAug 6, 2018Break; Break

  AS REPORTED BY THE USER FACILITY: UPON INSERTING THE CATHETER INTO THE LUMBAR REGION OF THE PATIENT, BREAKAGE OCCURRED AND A PIECE OF THE CATHETER WAS RETAINED INSIDE THE PATIENT. NEURO-SPINE WAS CONSULTED IMMEDIATELY AND EVALUATED THE PATIENT BEFORE ALLOWING THE PATIENT INTO THE OR. X-RAYS WERE CONDUCTED. THE PHYSICIAN DECIDED TO LEAVE THE BROKEN CATHETER PIECE IN THE PATIENT AND TO MONITOR THE SITUATION. THE PATIENT IS WITHOUT SYMPTOMS.

  Patient problems: Foreign Body In Patient

  MAUDE report 7754184 ↗
• MalfunctionJun 26, 2017Break; Break

  AS REPORTED BY THE USER FACILITY: THE "EPIDURAL CATHETER DIDN'T FEEL RIGHT UPON REMOVAL". DURING REMOVAL OF THE CATHETER, THE CLINICIAN REPORTED HEARING A "POP" SOUND AND NOTICED THE DISTAL END OF THE CATHETER WAS NOT PRESENT AND LEFT INSIDE OF THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6667616 ↗
• MalfunctionMar 28, 2017Break; Break

  AS REPORTED BY USER FACILITY: A 2 CM PIECE OF THE CATHETER TIP WAS NOTED TO BE MISSING WHEN REMOVED FROM THE PATIENT AT END OF CASE. PATIENT DID HAVE AN X-RAY BUT THE MISSING PIECE WAS NOT LOCATED. THEY ARE UNSURE IF TIP WAS MISSING PRIOR TO INSERTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6438866 ↗