Combined Spinal & Epidural 333197Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964179327), received between Nov 18, 2019 and Nov 12, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Sep 18, 2025Class IIOpen, Classified

   Potential for the lid of the catheter connector to be in the incorrect position.

   Z-0123-2026 · Root cause: Process control · Recall details · FDA record ↗

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.

• MalfunctionNov 12, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: FX CATHETERS ARE KINKING, BEING STRETCHED TOO FAR AND SNAPPING OFF. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534584 ↗
• MalfunctionSep 11, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CATHETER METAL COIL EXPOSED, AND SOME LEFT IN PATIENT CAUSING DISCOMFORT. DETAILED INQUIRY DESCRIPTION: DURAL PUNCTURE MADE WITH 27 GUAGE NEEDLE. PT FELT RIGHT SIDED DISCOMFORT/PAIN IN RIGHT HIP BUT DID NOT DESCRIBE AS PARESTHESIA. PAIN WENT AWAY WITH SPINAL NEEDLE REMOVAL. UPON THREADING THE EPIDURAL CATHETER (WENT IN SMOOTH) PT FELT THE SAME DISCOMFORT ON THE RIGHT SIDE. WENT THROUGH STANDARD PROCESS OF REMOVING EPIDURAL FOR REPLACEMENT. AFTER NEEDLE REMOVED BEGAN PULLING BACK CATHETER AND MET A LITTLE RESISTANCE. WITH GENTLE STEADY TRACTION, THE CATHETER WAS SLIDING BACK EASILY BUT FOUND TO BE SEVERED AT APPROXIMATELY THE 5CM MARK WITH THE MENTAL INTER COIL STILL INTACT. SLOW TRACTION APPLIED TO THE METAL COIL WAS BEING USED TO GENTLY REMOVE AS MUCH AS POSSIBLE. AFTER MOST OF THE MENTAL COIL WAS REMOVED IT DID BREAK, LEAVING AN UNKNOWN AMOUNT STILL IN THE BACK.

  Patient problems: Discomfort; Foreign Body In Patient; Pain

  MAUDE report 23026803 ↗
• MalfunctionNov 18, 2019Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING THORACOTOMY FOR DIAPHRAGMATIC HERNIA REPAIR ON (B)(6) 2019. PATIENT RECEIVED AN THORACIC EPIDURAL AND WAS TAPED TO THE PATIENT'S BACK. PATIENT WAS MOVED FROM STRETCHER TO OR BED AND PROVIDER NOTICED THE CATHETER HAD COMPLETED SHEARED OFF IN HALF. THE CAUSE OF THE CATHETER SHEARING APPEARS TO HAVE BEEN SOME TENSION PLACED ON CATHETER AS THE PATIENT WAS MOVING. HALF OF THE CATHETER WAS STILL INSIDE THE PATIENT TAPED TO HER BACK. AS THIS IS A PAINFUL PROCEDURE, THE PATIENT NEEDED A PAIN CONTROL MODALITY BESIDE IV NARCOTICS AND AS PATIENT HAD JUST RECEIVE PREOPERATIVE HEPARIN, ANOTHER EPIDURAL WAS UNABLE TO BE PLACED. PATIENT RECEIVED POST OP TRUNCAL NERVE BLOCK (AN ADDITIONAL INVASIVE PROCEDURE).

  Patient problems: Foreign Body In Patient; Needle Stick/Puncture

  MAUDE report 9335004 ↗