Perifix® 332200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964178061), received between Apr 11, 2018 and Aug 15, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: ON MONDAY (B)(6) 2025 A PATIENT HAD AN EPIDURAL CATHETER PLACED INTRAOPERATIVELY FOR PAIN CONTROL FOLLOWING A MULTI-LEVEL POSTERIOR SPINAL FUSION. ON POD 2 WHEN THE PA WAS REVVING THE CATHETER, IT SEPARATED, AND A SECTION OF THE CATHETER REMAINED IN THE PATIENT'S BACK. THE PATIENT RETURNED TO THE OR LATER THAT AFTERNOON FOR AN EXPLORATION OF THE POST-OP LUMBAR WOUND AND REMOVAL OF THE RETAINED EPIDURAL CATHETER. THE SEGMENT WAS SUCCESSFULLY REMOVED. BOTH THE ANESTHESIOLOGIST & THE SURGEON FEEL THAT THE CATHETER WAS DEFECTIVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22814797 ↗
• InjuryJul 10, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: ON MONDAY (B)(6) 2025 A PATIENT HAD AN EPIDURAL CATHETER PLACED INTRAOPERATIVELY FOR PAIN CONTROL FOLLOWING A MULTI-LEVEL POSTERIOR SPINAL FUSION. ON POD 2 WHEN THE PA WAS REVVING THE CATHETER, IT SEPARATED, AND A SECTION OF THE CATHETER REMAINED IN THE PATIENT'S BACK. THE PATIENT RETURNED TO THE OR LATER THAT AFTERNOON FOR AN EXPLORATION OF THE POST-OP LUMBAR WOUND AND REMOVAL OF THE RETAINED EPIDURAL CATHETER. THE SEGMENT WAS SUCCESSFULLY REMOVED. BOTH THE ANESTHESIOLOGIST & THE SURGEON FEEL THAT THE CATHETER WAS DEFECTIVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22468094 ↗
• InjuryJul 9, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: ON MONDAY, (B)(6) 2025 A PATIENT HAD AN EPIDURAL CATHETER PLACED INTRAOPERATIVELY FOR PAIN CONTROL FOLLOWING A MULTI-LEVEL POSTERIOR SPINAL FUSION. ON POD 2 WHEN THE PA WAS REVVING THE CATHETER, IT SEPARATED, AND A SECTION OF THE CATHETER REMAINED IN THE PATIENT'S BACK. THE PATIENT RETURNED TO THE OR LATER THAT AFTERNOON FOR AN EXPLORATION OF THE POST-OP LUMBAR WOUND AND REMOVAL OF THE RETAINED EPIDURAL CATHETER. THE SEGMENT WAS SUCCESSFULLY REMOVED. BOTH THE ANESTHESIOLOGIST AND THE SURGEON FEEL THAT THE CATHETER WAS DEFECTIVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22457150 ↗
• MalfunctionApr 11, 2018Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT 22CM OF THE 20G CATHETER SHEARED OFF IN A PATIENT WHILE PULLING BACK THROUGH THE18G NEEDLE. PATIENT WAS SEEN IN FOR CAUDALLY THREADED EPIDURAL INFUSION UP TO L5/S1 LEVEL. SACRAL HIATUS WAS IDENTIFIED UNDER FLUOROSCOPY. AREA WAS PREPPED AND DRAPED IN ROUTINE MANNER. SKIN AND SUBCUTANEOUS TISSUE WERE INFILTRATED WITH 4 ML OF 1% LIDOCAINE. USING A 17 GAUGE 3.5 INCH TOUHY NEEDLE THE CAUDAL EPIDURAL SPACE WAS CONFIRMED UNDER FLUOROSCOPY. THE EPIDURAL CATHETER WAS THREADED THROUGH TOUHY NEEDLE AND 2ML OF CONTRAST SPREAD WAS VISUALIZED AT L5/S1 LEVEL. AFTER NEGATIVE ASPIRATION A TOTAL OF 10ML OF 0.5% LIDOCAINE WITH 80MG OF DEPOMEDROL WAS INJECTED WITHOUT RESISTANCE. THERE WAS NO EVIDENCE OF SPINAL ANESTHESIA OR INTRAVASCULAR INJECTION. UPON REMOVAL OF CATHETER IT WAS NOTICED THAT TIP WAS NOT INTACT. THERE WAS NO RESISTANCE DURING CATHETER REMOVAL. PATIENT HAD NO INCREASED PAIN, NUMBNESS OR BLE WEAKNESS. NO LOSS OF BOWEL/BLADDER FUNCTION. ORTHOPEDICS SPINE WAS CONSULTED REGARDING POSSIBLE INTERVENTION REGARDING RETAINED CATHETER WHICH IS ABOUT 20CM. PATIENT AND HIS WIFE WERE SPOKEN TO AFTER PROCEDURE AND INFORMED OF RETAINED CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 7421734 ↗