Perifix® 332230Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964178467), received between Jan 29, 2020 and Sep 29, 2022 — 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.

• MalfunctionSep 29, 2022Break; Break

  AS PER MEDWATCH NUMBER MW5111743: DESCRIPTION: FIRST ATTEMPT TO PLACE EPIDURAL RESULTED IN COMPLICATIONS - EPIDURAL SPACE WAS ACCESSED WITH MINIMAL DIFFICULTY AFTER ADJUSTING PATIENT POSITION, AND CATHETER WAS THREADED INTO THE SPACE WITHOUT DIFFICULTY OR RESISTANCE. AS NEEDLE WAS SLOWLY REMOVED AFTER CATHETER PLACEMENT, WITH VERY SLIGHT RESISTANCE AS IT WAS RETRACTED THROUGH THE PATIENT'S LIGAMENTS, I FELT A DISTINCT POP IN THE HAND THAT WAS SUPPORTING THE EPIDURAL CATHETER, AND UPON REMOVAL OF THE CATHETER FOLLOWING THIS POP DISCOVERED THE DISTAL PORTION HAD SHEARED OFF DURING NEEDLE REMOVAL. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15501752 ↗
• MalfunctionJan 29, 2020Break; Break

  AS REPORTED BY MEDWATCH NUMBER MW5091909: "PATIENT UNDERWENT CERVICAL STEROID INJECTION. THE INJECTION WAS ADMINISTERED ON FIRST PASS WITHOUT ANY DOCUMENTED COMPLICATIONS ON (B) (6)2019. THE PATIENT REPORTED LEFT ARM WEAKNESS. CT ORDERED AND PT. OUTPATIENT CT OF CERVICAL SPINE W/CONTRAST, MYELOGRAM-CENTRAL-CORD EXPANDED FROM C4-C7. LIKELY AN INTRAMEDULLARY HEMATOMA. THERE IS A 3MM NEEDLE FRAGMENT DORSAL TO THE CORD AT C6-C7. PATIENT ADMITTED FOR OBSERVATION."

  Patient problems: Foreign Body In Patient; Hematoma

  MAUDE report 9645289 ↗