EspocanRecalls & reported problems across all models
B. Braun Medical Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Espocan model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 7 models of Espocan by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Feb 10, 2017 and Dec 3, 2025 — classified as 1 injury, 25 malfunctions.
The most frequently reported specific device problem is “Break” (16 reports).
1 FDA recall record 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
Reports received per month, all models
Espocan 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.
- Sep 18, 2025Open, Classified
Potential for the lid of the catheter connector to be in the incorrect position.
Z-0122-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported Espocan problems
Device problems
- Break16
- Detachment of Device or Device Component8
- Difficult to Advance2
Patient problems
- Foreign Body In Patient10
- No Known Impact Or Consequence To Patient8
- Device Embedded In Tissue or Plaque3
- Needle Stick/Puncture3
- Headache2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- Pain1
Espocan models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Espocan® 333196Spinal epidural anesthesia kit1 recall1 report
- Espocan® 333196Spinal epidural anesthesia kit11 reports
- Espocan® 333192Spinal epidural anesthesia kit7 reports
- Espocan® 333165Spinal epidural anesthesia kit3 reports
- Espocan® 333194Spinal epidural anesthesia kit2 reports
- Espocan® 333182Spinal epidural anesthesia kit1 report
- Espocan® 333151Spinal epidural anesthesia kit1 report
Recent Espocan adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2025Break; Break
AS REPORTED BY THE USER FACILITY: A NURSE WAS HELPING A PATIENT OUT OF BED AND FOUND THAT THE CATHETER HAD BROKEN, WITH SOME OF THE CATHETER STILL IN THE PATIENT'S BACK. THE NURSE REMOVED THE REMAINDER OF THE CATHETER, ENSURING THE TIP WAS INTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704376 ↗MalfunctionJan 7, 2025Break; Break
AS REPORTED BY THE USER FACILITY: PHYSICIAN REPORTED MULTIPLE PROBLEMS WITH ABOVE-MENTIONED PRODUCT CLAMP0 NOT CLOSING PROPERLY, DIFFICULTY WITH MEDICATION DELIVERY-DIFFICULT TO PUSH, AND CLAIM NOT FUNCTIONING PROPERLY RESULTING IN RETAINED OBJECT. UNFORTUNATELY LOT NUMBERS WERE NOT CAPTURED AS PRODUCT WAS DISCARDED. VPCO REEDUCATED ON SAVINGS PRODUCTS TO ROOT CAUSE AND APPROPRIATELY REPORT. PHYSICIAN ADVISED WILL UPTRAIN TEAM ON APPROPRIATE HANDLING OF FAILED PRODUCTS TO CAPTURE LOT NUMBER TO ROOT CAUSE.. ISSUES STARTED IN JUNE 2024 WITH DIFFICULTY IN PUSHING MEDICATION. DR. HASSAN IQBAL CONTACTED VENDOR TO REPORT AND VENDOR REVAMPED KIT WITH RESOLUTION. NO REPEAT OCCURRENCES REPORTED UNTIL APPROXIMATELY OCTOBER WHEN SEVERAL END-USERS REPORTED DIFFICULTY WITH PUSHING MEDICATION. DR. IQBAL PERSONALLY LED CASE AND REPLICATED DIFFICULTY WITH PUSHING MEDICATIONS. ON A SEPARATE CASE ON 12/17/24, MORBIDLY OBESE PATIENT USED SAME EPIDURAL TRAY AND CATHETER SHREDDED AND RETAINED BODY LEFT IN PATIENT. REPORTED TO SUPPLY CHAIN AND VENDOR CONTACTED. VENDOR OFFERED TO REPLACE CATHETERS. SUPPLY CHAIN DIRECTOR REPORTED TO VP CLINICAL OPERATIONS. VP ADVISED PATIENT SAFETY OFFICER AND ENTERED PRO
Patient problems: Foreign Body In Patient
MAUDE report 21091937 ↗MalfunctionMay 1, 2024Break; Break
AS REPORTED BY THE USER FACILITY: DESCRIPTION SUMMARY: WANTED TO MAKE EVERYONE AWARE WE HAD AN EPIDURAL CATH THAT BROKE OFF INTO A PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 19220350 ↗MalfunctionApr 29, 2024Break; Break
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION - "AN EPIDURAL CATH THAT BROKE OFF INTO A PATIENT." DESCRIPTION OF THE PATIENT EVENT - "EPIDURAL CATH BROKE OFF INTO PATIENT." NO INJURY REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 19202175 ↗MalfunctionMar 19, 2024Break; Break
AS REPORTED BY THE USER FACILITY: WRITING TO REPORT A BROKEN CATHETER FROM THIS PRODUCT: PRODUCT: ESPOCAN COMBINED SPINAL AND EPIDURAL ANESTHESIA KIT LOT: 0061917773. PRODUCT#: ES1827K. A 2 CM PORTION REPORTED TO BE RETAINED PER MDA.
Patient problems: Foreign Body In Patient
MAUDE report 18928520 ↗MalfunctionOct 17, 2023Break; Break
AS REPORTED BY THE USER FACILITY: EPIDURAL CATHETER INSERTION WAS UNEVENTFUL. UPON REMOVAL OF THE EPIDURAL, THE CATHETER FRACTURED, AND SOME PART OF THE CATHETER WAS RETAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 17948488 ↗MalfunctionApr 11, 2023Break; Break
AS REPORTED BY THE USER FACILITY: CRNA INSERTED AN EPIDURAL CATHETER FOR PATIENT'S VAGINAL DELIVERY. WHEN REMOVING THE CATHETER, NURSE OBSERVED THAT THE TIP OF THE CATHETER WAS MISSING, AND THE END WAS IRREGULAR. NURSE THAT REMOVED CATHETER INDICATED THERE WAS NO RESISTANCE DURING REMOVAL. THE B. BRAUN CATHETER WAS COMPARED TO OTHERS, AND IT WAS DETERMINED TO BE 2.25 INCHES SHORTER THAN THE OTHER UNUSED CATHETERS. THE PATIENT WAS X-RAYED, AND NOTHING WAS FOUND. PATIENT WAS NOT SYMPTOMATIC. PATIENT WAS DISCHARGED THE NEXT DAY. THE OB PROVIDER REACHED OUT TO A NEUROSURGEON. THE NEUROSURGEON RECOMMENDED ADDITIONAL RADIOLOGICAL VIEWS (4 CERVICAL VIEWS; SACRAL, L-S, AP LATERAL VIEW) OF THE PATIENT. THE PATIENT HAD ADDITIONAL XRAYS OF HER THORACIC SPINE, SKULL, CERVICAL SPINE AND SACRUM/COCCYX AREA AND NO FOREIGN BODY WAS FOUND.
Patient problems: Foreign Body In Patient
MAUDE report 16711972 ↗MalfunctionMay 18, 2022Break; Break
AS REPORTED BY THE USER FACILITY: THE PATIENT GAVE INFORMED CONSENT FOR COMBINED SPINAL EPIDURAL (CSE) ANESTHESIA AND WAS BROUGHT TO AN OPERATING ROOM. THE PATIENT ASSUMED A SITTING POSITION, AND AN ANESTHESIOLOGY RESIDENT, WHO WAS APPROXIMATELY HALFWAY THROUGH THEIR CA1 YEAR (RESIDENT IN FIRST YEAR OF CLINICAL ANESTHESIOLOGY TRAINING), PERFORMED LOCAL INFILTRATION WITH APPROXIMATELY 3 ML OF LIDOCAINE 1% AT THE MIDLINE OF THE L5/S1 INTERSPACE USING A 27-GAUGE NEEDLE THAT WAS 3.2 CM IN LENGTH ATTACHED TO A 3-ML LUER LOCK SYRINGE. THE CSE KIT USED WAS AN EPOSCAN COMBINED SPINAL AND EPIDURAL ANESTHESIA TRAY MANUFACTURED BY B. BRAUN MEDICAL. A CSE TECHNIQUE WAS THEN ATTEMPTED AT THIS INTERSPACE, AND INSERTION OF THE 12.7-CM PENCAN 25-GAUGE SPINAL NEEDLE THROUGH THE TUOHY NEEDLE DID NOT PRODUCE BACKFLOW OF CEREBROSPINAL FLUID. RATHER THAN ADMINISTER ANESTHESIA IN THE EPIDURAL SPACE, THE PLAN WAS TO REATTEMPT A CSE AT A DIFFERENT LUMBAR INTERSPACE. THE ANESTHESIOLOGY RESIDENT PROVIDED LOCAL INFILTRATION AT THE L4/L5 INTERSPACE WITH AN ADDITIONAL 3 ML OF LIDOCAINE 1% WITH THE SAME 27-GAUGE NEEDLE. IN CONDUCTING THIS LOCAL ANESTHETIC INFILTRATION, THE RESIDENT INSERTED THE NEEDLE SUPERIOR
Patient problems: Foreign Body In Patient; Needle Stick/Puncture
MAUDE report 14427196 ↗MalfunctionMay 5, 2022Difficult to Advance; Difficult to Advance
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: WE HAVE BEEN HAVING ISSUES WITH FREQUENT INTRAVASCULAR CATHETERS WITH BOTH THE CSE AND EPIDURAL KITS. THE CATHETER SEEMS TO BE "MORE STIFF" IF THAT MAKES SENSE. THE OTHER ISSUE WITH THE KITS, IS THAT THE GLASS LOR SYRINGES ARE "STICKING." WE WET THEM WITH THE SALINE MULTIPLE TIMES, BUT THE SYRINGES STICK AND DO NOT GLIDE SMOOTHLY. AS FAR AS PTS BEING AFFECTED, THE INTRAVASCULAR CATHETERS HAVE NOT HAD AN ADVERSE EFFECTS FOR THE PATIENTS, BUT HAVE RESULTED IN LONGER PLACEMENT TIMES ALONG WITH MULTIPLE PLACEMENT ATTEMPTS. THE LOR SYRINGE ISSUE DID RESULT ON ONE WET TAP DURING PLACEMENT. THIS DID REQUIRE A BLOOD PATCH.
Patient problems: Headache; Needle Stick/Puncture
MAUDE report 14285558 ↗MalfunctionMay 3, 2022Difficult to Advance; Difficult to Advance
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: WE HAVE BEEN HAVING ISSUES WITH FREQUENT INTRAVASCULAR CATHETERS WITH BOTH THE CSE AND EPIDURAL KITS. THE CATHETER SEEMS TO BE "MORE STIFF" IF THAT MAKES SENSE. THE OTHER ISSUE WITH THE KITS, IS THAT THE GLASS LOR SYRINGES ARE "STICKING." WE WET THEM WITH THE SALINE MULTIPLE TIMES, BUT THE SYRINGES STICK AND DO NOT GLIDE SMOOTHLY. THE INTRAVASCULAR CATHETERS HAVE NOT HAD AN ADVERSE EFFECTS FOR THE PATIENTS, BUT HAVE RESULTED IN LONGER PLACEMENT TIMES ALONG WITH MULTIPLE PLACEMENT ATTEMPTS. THE LOR SYRINGE ISSUE DID RESULT ON ONE WET TAP DURING PLACEMENT. THIS DID REQUIRE A BLOOD PATCH.
Patient problems: Headache; Needle Stick/Puncture
MAUDE report 14270129 ↗InjuryAug 14, 2020Break; Break
AS REPORTED BY THE USER FACILITY: WIRE FROM FX SPRINGWOUND CATHETER WAS LEFT IN PATIENT'S BACK. DETAILS OF REPORT: PATIENT HAD FIRST EPIDURAL PLACED UNSUCCESSFULLY (NOT A B.BRAUN PRODUCT) TRIED THIS DEVICE FOR 2ND ATTEMPT, ALSO UNSUCCESSFUL. USED A 3RD KIT (NOT A B.BRAUN PRODUCT) TO SUCCESSFULLY PLACE EPIDURAL. WHEN PLACING CATHETER ON SECOND ATTEMPT RESISTANCE WAS MET, "FELT LIKE A BURR". REMOVED NEEDLE AND CATHETER TOGETHER, BUT PART OF CATHETER REMAINED, NOTED METAL IN SKIN. PATIENT WAS TRANSFERRED TO ANOTHER FACILITY TO HAVE CT SCAN OF ARE DUE TO PARESTHESIA OF THE SKIN FROM RIB CAGE DOWN MOST PRONOUNCED TO LEGS FRONT AND BACK. CT REVEALED A METAL WIRE FRAGMENT. SURGERY TO REMOVE FRAGMENT REVEALED APPROXIMATELY 10 CM OF CATHETER FROM PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 10406461 ↗MalfunctionMay 11, 2020Break; Break
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE PATIENT DID NOT GET RELIEF FROM THE EPIDURAL AND THE CATHETER NEEDED TO BE REMOVED. DURING THE REMOVAL PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS TORN IN TWO. NO PIECE WAS RETAINED. NO LEAKAGE WAS NOTED DURING THE TREATMENT. NO INJURY REPORTED.
Patient problems: Pain; Therapeutic Response, Decreased
MAUDE report 10042608 ↗MalfunctionOct 17, 2019Break; Break
AS REPORTED BY THE USER FACILITY: REPORT STATES THAT IT WAS NOTICED THAT THE CATHETER TIP WAS MISSING WHEN REMOVED FROM THE PATIENT. THERE WAS APPROXIMATELY 3-3.5CM RETAINED IN THE PATIENT'S EPIDURAL SPACE. AN XRAY AND CT SCAN WERE PERFORMED. BASED ON THE RESULTS, THE PATIENT MET WITH THE NEUROSURGERY AND DID NOT HAVE THE TIP REMOVED AT THE TIME OF DISCHARGE.
Patient problems: Foreign Body In Patient
MAUDE report 9202620 ↗MalfunctionSep 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY: EVENT 3: CUSTOMER REPORTS, "WE HAVE HAD ABOUT 7 INSTANCES WHERE THE CATHETER CONNECTOR COMES OFF OF THE EPIDURAL." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9075108 ↗MalfunctionSep 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY: EVENT 5: CUSTOMER REPORTS, "WE HAVE HAD ABOUT 7 INSTANCES WHERE THE CATHETER CONNECTOR COMES OFF OF THE EPIDURAL." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9075107 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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