Combined Spinal & EpiduralRecalls & reported problems across all models

We found 3 models of Combined Spinal & Epidural by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2019 and Nov 12, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

3 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Combined Spinal & Epidural recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 18, 2025Open, 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 ↗

2. Jul 10, 2019Terminated

   The filter capacity is not achieved due to damage of the filter membrane.

   Z-2467-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Jul 10, 2019Terminated

   The filter capacity is not achieved due to damage of the filter membrane.

   Z-2466-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Combined Spinal & Epidural problems

Combined Spinal & Epidural models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Combined Spinal & Epidural 333197

  Spinal epidural anesthesia kit
  1 recall3 reports
• Combined Spinal & Epidural 339114

  Epidural anesthesia kit
  1 recall2 reports
• Combined Spinal & Epidural 339115

  Epidural anesthesia kit
  1 recall0 reports

Recent Combined Spinal & Epidural adverse event reports

The 5 most recent reports across all models, 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 ↗
• MalfunctionMar 7, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE EVENT DESCRIPTION: "CATHETER BROKE DOWN IN PATIENT BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549633 ↗
• MalfunctionJan 16, 2025Break; Break

  ACCORDING EVENT DESCRIPTION: CATHETER SNAPPED DURING INSERTION OF EPIDURAL CATHETER PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170736 ↗
• 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 ↗

Other B. Braun Medical Inc. products

• Infusomat54 models · 2,783 reports · 30 recalls
• IV Administration Set153 models · 281 reports · 68 recalls
• Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
• Outlook25 models · 195 reports · 24 recalls
• Perifix57 models · 224 reports · 20 recalls
• Extension Set41 models · 101 reports · 16 recalls
• Design Options116 models · 132 reports · 14 recalls
• Blood Administration Set24 models · 177 reports · 13 recalls