Perifix® 552047Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964665196), received between Mar 21, 2017 and Mar 19, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025Break; Break

  AS REPORTED BY MEDWATCH MW5166611: DESCRIBE EVENT OR PROBLEM: WHEN GOING TO REMOVE THE EPIDURAL CATHETER, THE RN NOTICED THAT THE EPIDURAL CATHETER WAS DISCONNECTED. HOWEVER, THE TUBING HAD BROKEN OFF OF THE CLAMP. IT WAS DISCONNECTED BY ANOTHER RN. THE PATIENT HAD STATED THAT HER EPIDURAL WAS WEARING OFF AND SHE COULD FEEL "ALMOST EVERYTHING" WHILE SHE WAS PUSHING. STAFF DISPOSED OF THE PRODUCT INSTEAD OF HOLDING FOR REVIEW / INVESTIGATION. NO CUSTOMER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643931 ↗
• MalfunctionApr 26, 2021Break; Break

  AS REPORTED BY THE USER FACILITY: DURING PLACEMENT OF THE EPIDURAL ON A LABORING PATIENT, THE EPIDURAL CATHETER TIP (APPROXIMATELY 0.2CM) WAS FOUND MISSING WHEN PULLED OUT FROM THE TOUHY NEEDLE. THE CATHETER WAS REMOVED BY A CRNA PERFORMING THE PROCEDURE DUE TO AN INABILITY TO PASS THE CATHETER THROUGH THE EPIDURAL TUOHY NEEDLE INTO THE EPIDURAL SPACE. BECAUSE IT WOULD NOT GO THROUGH, THE CATHETER WAS PULLED IN ORDER TO RE-CHECK LOSS OF RESISTANCE. THERE WAS NO RESISTANCE WHEN IT WAS PULLED. IT LIKELY SHEARED WHEN THE NEEDLE WAS ADVANCE FORWARD WITH THE CATHETER STILL INSIDE THE NEEDLE (A COMMON PRACTICE TO GET THE TIP FURTHER INTO THE EPIDURAL SPACE). CLINICIAN DISCUSSED WITH THE PATIENT THE BENIGN NATURE OF THE CATHETER, DIFFICULTY LOCATING THE BROKEN PIECE (DID NOT SHOW UP IN 3-VIEW LUMBAR X-RAY), AND DIFFICULTY WITH SURGICAL REMOVAL, AND THE PATIENT AT THIS TIME HAS NOT REQUEST FOR IT TO BE REMOVED. NO OTHER INJURIES/COMPLICATION HAVE BEEN IDENTIFIED AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 11726743 ↗
• MalfunctionMar 21, 2017Break; Break

  AS REPORTED BY USER FACILITY: A PROVIDER WAS PLACING A LABOR EPIDURAL AND COULD NOT ADVANCE THE CATHETER PAST 12CM, AND WHEN PULLING THE TUOHY AND CATHETER OUT MET RESISTANCE WITH THE CATHETER. THE PLASTIC CATHETER WAS BEING REMOVED WHEN THE PLASTIC STOPPED AND ONLY THE SPRINGWOUND WIRE WAS BEING PULLED FROM THE PATIENT. THE WIRE WAS REMOVED AND THE REMAINING PIECE OF PLASTIC WAS STILL ATTACHED AND THEY WERE ABLE TO REMOVE THE PIECE INTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6420883 ↗