Perifix® 333532Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964179969), received between Apr 4, 2023 and Jul 2, 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 2, 2025Break; Break

  AS REPORTED VIA MEDWATCH NUMBER MW5171434: DESCRIBE EVENT OR PROBLEM: POSTPARTUM COURSE WAS UNCOMPLICATED FROM AN OBSTETRIC PERSPECTIVE ALTHOUGH PATIENT RETAINED FRAGMENT OF EPIDURAL CATHETER FOLLOWING REMOVAL BY ANESTHESIA. THEY'RE CONCERNS FOR POSSIBLE RETAINED CATHETER FRAGMENT APPROXIMATELY 1 CM IN LENGTH PRESUMED TO BE RETAINED SUBCUTANEOUSLY. THE PATIENT, LABOR AND DELIVERY (L&D) NURSES AND SUPERVISING ANESTHESIA ATTENDING WERE IMMEDIATELY INFORMED. A DECISION WAS MADE TO OBTAIN A COMPUTED TOMOGRAPHY (CT) SCAN OF THE LUMBAR SPINE TO EVALUATE FOR RETAINED CATHETER FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22382781 ↗
• MalfunctionApr 4, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: REPORTED ISSUE: APPROXIMATELY 2CM OF THE DISTAL PORTION OF THE CATHETER WAS RETAINED IN THE PATIENT FOLLOWING THE REMOVAL OF THE CATHETER. THE DEVICE FRAGMENT IS IN THE PATIENT'S CAUDAL AREA AND COULD NOT BE REMOVED WITHOUT AN ADDITIONAL SURGICAL PROCEDURE. REPORTEDLY THE SURGEON EXPLAINED THE EMBEDDED FRAGMENT TO THE PATIENT AND THAT REMOVAL WOULD REQUIRE AN ACTUAL IN-PATIENT SURGERY. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND TOLD THAT THE DEVICE IS MADE OF MATERIAL THAT CAN BE SURGICALLY IMPLANTED FOR A LONG PERIOD OF TIME AND THAT THERE IS A VERY LOW CHANCE OF "HIGH RATE OF INFECTION". THE PATIENT HAS OPTED TO NOT HAVE THE DEVICE FRAGMENT REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16676356 ↗