PerifixRecalls & reported problems across all models
B. Braun Medical Inc. · 57 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
13 open recalls name at least one Perifix model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 224
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 20
We found 57 models of Perifix by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 224 adverse event reports in the FDA's MAUDE database, received between Nov 21, 2016 and Sep 25, 2026 — classified as 18 injuries, 206 malfunctions.
The most frequently reported specific device problem is “Break” (162 reports).
20 FDA recall records name at least one of these models by its device identifier, 13 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
Perifix 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-0121-2026 · Root cause: Process control · Recall details · FDA record ↗
- Sep 18, 2025Open, Classified
Potential for the lid of the catheter connector to be in the incorrect position.
Z-0120-2026 · Root cause: Process control · Recall details · FDA record ↗
- Sep 18, 2025Open, Classified
Potential for the lid of the catheter connector to be in the incorrect position.
Z-0119-2026 · Root cause: Process control · Recall details · FDA record ↗
- Sep 18, 2025Open, Classified
Potential for the lid of the catheter connector to be in the incorrect position.
Z-0118-2026 · Root cause: Process control · Recall details · FDA record ↗
- Sep 18, 2025Open, Classified
Potential for the lid of the catheter connector to be in the incorrect position.
Z-0117-2026 · Root cause: Process control · Recall details · FDA record ↗
- Sep 18, 2025Open, Classified
Potential for the lid of the catheter connector to be in the incorrect position.
Z-0116-2026 · Root cause: Process control · Recall details · FDA record ↗
- Sep 18, 2025Open, Classified
Potential for the lid of the catheter connector to be in the incorrect position.
Z-0115-2026 · Root cause: Process control · Recall details · FDA record ↗
- Sep 18, 2025Open, Classified
Potential for the lid of the catheter connector to be in the incorrect position.
Z-0114-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 22, 2024Open, Classified
Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
Z-1150-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jan 22, 2024Open, Classified
Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
Z-1149-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jul 31, 2023Open, Classified
Product may be mislabeled with an incorrect lid stock label.
Z-2627-2023 · Root cause: Process control · Recall details · FDA record ↗
- Jun 5, 2023Open, Classified
Kits were assembled with the incorrect Filter Straw.
Z-2002-2023 · Root cause: Mixed-up of materials/components · names 4 of these models · Recall details · FDA record ↗
- May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1591-2022 · Root cause: Environmental control · Recall details · FDA record ↗
- Jul 10, 2019Terminated
The filter capacity is not achieved due to damage of the filter membrane.
Z-2474-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jul 10, 2019Terminated
The filter capacity is not achieved due to damage of the filter membrane.
Z-2473-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jul 10, 2019Terminated
The filter capacity is not achieved due to damage of the filter membrane.
Z-2472-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jul 10, 2019Terminated
The filter capacity is not achieved due to damage of the filter membrane.
Z-2471-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jul 10, 2019Terminated
The filter capacity is not achieved due to damage of the filter membrane.
Z-2470-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jul 10, 2019Terminated
The filter capacity is not achieved due to damage of the filter membrane.
Z-2469-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jul 10, 2019Terminated
The filter capacity is not achieved due to damage of the filter membrane.
Z-2468-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Perifix problems
Device problems
- Break162
- Detachment of Device or Device Component23
- Contamination /Decontamination Problem18
- Difficult to Remove7
- Leak/Splash5
- Device Operates Differently Than Expected3
- Air/Gas in Device2
- Material Deformation2
Patient problems
- Foreign Body In Patient104
- No Clinical Signs, Symptoms or Conditions55
- No Known Impact Or Consequence To Patient40
- Needle Stick/Puncture10
- Device Embedded In Tissue or Plaque7
- No Consequences Or Impact To Patient6
- Pain5
- Cerebrospinal Fluid Leakage2
Perifix models
57 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Perifix® 332079Epidural anesthesia kit1 recall45 reports
- Perifix® 332097Epidural anesthesia kit1 recall39 reports
- Perifix® 332220Epidural anesthesia kit1 recall21 reports
- Perifix® 332078Epidural anesthesia kit1 recall12 reports
- Perifix® 332079Epidural anesthesia kit1 recall7 reports
- Perifix® 332097Epidural anesthesia kit1 recall5 reports
- Perifix® 332152Anesthesia conduction kit1 recall2 reports
- Perifix® 332217Epidural anesthesia kit1 recall2 reports
- Perifix® 332238Epidural anesthesia kit1 recall1 report
- Perifix® 332250Epidural anesthesia kit1 recall1 report
- Perifix® 332078Epidural anesthesia kit1 recall0 reports
- Perifix® 332086Epidural anesthesia kit1 recall0 reports
- Perifix® 332098Epidural anesthesia kit1 recall0 reports
- Perifix® 332077Epidural anesthesia kit1 recall0 reports
- Perifix® 332248Epidural anesthesia kit1 recall0 reports
- PERIFIX™ 339160Syringe, piston1 recall0 reports
- Perifix® 339183Epidural anesthesia kit1 recall0 reports
- Perifix® 339186Epidural anesthesia kit1 recall0 reports
- Perifix® 339187Epidural anesthesia kit1 recall0 reports
- Perifix® 339188Epidural anesthesia kit1 recall0 reports
- Perifix® 339191Epidural anesthesia kit1 recall0 reports
- Perifix® 339189Epidural anesthesia kit1 recall0 reports
- Perifix® 332093Epidural anesthesia kit1 recall0 reports
- Perifix® 333512Epidural anesthesia kit16 reports
- Perifix® 332081Epidural anesthesia kit11 reports
- Perifix® 332098Epidural anesthesia kit4 reports
- Perifix® 332200Epidural anesthesia kit4 reports
- Perifix® 332254Epidural anesthesia kit4 reports
- Perifix® 332282Epidural anesthesia kit4 reports
- Perifix® 332209Epidural anesthesia kit3 reports
- Perifix® 332215Epidural anesthesia kit3 reports
- Perifix® 332216Epidural anesthesia kit3 reports
- Perifix® 333521Epidural anesthesia kit3 reports
- Perifix® 333540Epidural anesthesia kit3 reports
- Perifix® 552047Epidural anesthesia kit3 reports
- Perifix® 332086Epidural anesthesia kit2 reports
- Perifix® 332230Epidural anesthesia kit2 reports
- Perifix® 332249Epidural anesthesia kit2 reports
- Perifix® 332285CATHETER, CONDUCTION, ANESTHETIC2 reports
- Perifix® 333514Epidural anesthesia kit2 reports
- Perifix® 333532Epidural anesthesia kit2 reports
- Perifix® 332075Epidural anesthesia kit1 report
- Perifix® 332082Epidural anesthesia kit1 report
- Perifix® 332084Epidural anesthesia kit1 report
- Perifix® 332167Anesthesia conduction kit1 report
- Perifix® 332202Epidural anesthesia kit1 report
- Perifix® 332221Epidural anesthesia kit1 report
- Perifix® 332224Epidural anesthesia kit1 report
- Perifix® 332235Epidural anesthesia kit1 report
- Perifix® 332290Epidural anesthesia kit1 report
- Perifix® 332292Epidural anesthesia kit1 report
- Perifix® 333520Epidural anesthesia kit1 report
- Perifix® 332600Epidural anesthesia kit1 report
- Perifix® 332605Epidural anesthesia kit1 report
- Perifix® 339190Epidural anesthesia kit1 report
- Perifix® 339193Epidural anesthesia kit1 report
- Perifix® 332095Epidural anesthesia kit1 report
Recent Perifix adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Break
As reported by the user facility:CRNA did an epidural on a patient and had an issue when he went to attach the connector. The end was frayed so he had to pull out and redo entire epidural.No injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896570 ↗MalfunctionSep 15, 2026Break
As reported by the user facility:Event 2:Epidural Catheter separationTwo epidural catheters broke off prior to completion of therapy, springwound coil became exposed. One catheter was missing tip and was not sealed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775188 ↗MalfunctionAug 7, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50173283 ↗MalfunctionAug 7, 2026Difficult to Remove
As reported by the user facility:Event 1:The epidural catheter ended up in a knot.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50173280 ↗MalfunctionMay 26, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: AN ADDITIONAL UNANNOUNCED SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS RECEIVED WITH NO KNOWN REPORTED DEFECT. HOWEVER, EVALUATION IDENTIFIED BLOODLINE LEAKAGE DUE TO A DAMAGED LOCKSITE. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25280050 ↗MalfunctionMay 11, 2026Break
AS REPORTED VIA MEDSUN (B)(4): IN (B)(6) 2026, DURING PLACEMENT OF AN EPIDURAL CATHETER, THE ANESTHESIOLOGIST OBSERVED THAT THE CATHETER HAD SHREDDED WHILE BEING ADVANCED INTO THE PATIENT'S BACK. THE BLUE TIP WAS NOTED TO BE MISSING FROM THE DISTAL END OF THE CATHETER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136212 ↗MalfunctionApr 20, 2026Break
AS REPORTED BY THE USER FACILITY: FX CATHETER SNAPPING DURING THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24924659 ↗MalfunctionApr 20, 2026Break
AS REPORTED BY THE USER FACILITY: SEVERAL CRNAS HAVE REPORTED AT LEAST 3 CATHETER DISCONNECTS OR BROKEN CATHETERS. IT IS UNCLEAR IF THE CATHETER SLIPPED OUT OF THE CONNECTOR OR IF THE CATHETER BROKE OFF. AT LEAST ONE INCIDENT REPORTED WHERE CATHETER "BROKE" AND A PIECE OF THE CATHETER REMAINED IN THE CONNECTOR. IN ADDITION, A CRNA OPENED A TRAY (332079) LOT 0062048547 AND APPLIED GENTLE/CONSTANT PULL TO THE CATHETER ON BOTH ENDS RESULTING IN THE CATHETER TO SNAP AND COME APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24924583 ↗MalfunctionMar 30, 2026Break
AS REPORTED BY THE USER FACILITY. EPIDURAL CATHETER "SHEARING OFF" IN PATIENT WHILE PROVIDER WAS ATTEMPTING TO PLACE.
Patient problems: Foreign Body In Patient
MAUDE report 24716498 ↗MalfunctionFeb 5, 2026Break
AS REPORTED BY THE USER FACILITY: CATHETER TIP BROKE OFF AT END OF TUOHY NEEDLE WHEN USED FOR PERIPHERAL BLOCK. FOREIGN MATTER REMAINS IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 24267575 ↗MalfunctionJan 27, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: UPON OPENING THE PRODUCT, IT WAS OBSERVED THAT A LONG PIECE OF HAIR WAS WRAPPED ON THE APPLICATOR. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24188455 ↗MalfunctionJan 16, 2026Break
AS REPORTED BY THE USER FACILITY: PRODUCT QUALITY EXCELLENCE WAS INCLUDED IN AN EMAIL STRING WHERE THE CHIEF OF ANESTHESIA INQUIRED ABOUT THE TIPS BREAKING OFF OF THE B. BRAUN EPIDURAL CATHETERS. ON (B)(6) 2026, CUSTOMER COMPLAINT ADVOCATE SPOKE TO THE CLINICAL PROCEDURE SPECIALIST WHO REPORTED THAT THE CHIEF OF ANESTHESIA REPORTED THAT SHE HEARD (FROM A COLLEAGUE) THAT B. BRAUN HAD ISSUES WITH THE TIPS BREAKING AND HE WANTED TO KNOW IF IT WAS RESOLVED. WHILE THE END USER DID NOT HAVE AN EVENT OCCUR WITH BREAKAGE, THIS COMPLAINT IS BEING FILED FOR THE THIRD-PARTY EVENT WITH NO ADDITIONAL INFORMATION BEING PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101405 ↗MalfunctionDec 17, 2025Break; Break
AS BY MEDSUN NUMBER (B)(4): DESCRIBE THE EVENT OR PROBLEM: ABLE TO GET TO INTRATHECAL SPACE WITH CSF (CEREBRAL-SPINAL FLUID) COMING BACK IN TOUHY NEEDLE ON FIRST ATTEMPT. CATHETER THREADED WITH NO RESISTANCE. ON WITHDRAWAL OF TOUHY NEEDLE, CATHETER TEARED AT 21 CM MARK. WENT TO REMOVE IT AND CATHETER PIECE HAD MIGRATED INTO THE THECAL SAC SO CASE WAS ABORTED. CATHETER PIECE REMAINS IN PATIENT BODY.
Patient problems: Foreign Body In Patient
MAUDE report 23833258 ↗MalfunctionDec 9, 2025Break; Break
AS REPORTED BY THE USER FACILITY: DESCRIBE EVENT OR PROBLEM: RETAINED EPIDURAL CATHETER FRAGMENT.
Patient problems: Foreign Body In Patient
MAUDE report 23763159 ↗MalfunctionNov 25, 2025Break; Break
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: THE EPIDURAL CATHETER INFUSION PUMP INITIALLY RAN WITHOUT ISSUE, THOUGH OFF SINCE OCCLUSION ALARM AND RESISTANCE TO FLUSH NOTED AT 1527. PER DISCUSSION WITH PROCEDURAL TEAM, UNEVENTFUL PLACEMENT, LOR-2 CM, CATHETER EASILY ADVANCED WITHOUT RESISTANCE, SECURED - 10CM W/ GLUE AND INFUSION INITIALLY RAN WITHOUT ISSUES. PATIENT REPOSITIONED ON THE LEFT SIDE AND CATHETER ASSESSED. NO APPARENT KINKING, ASPIRATION NEGATIVE SIGNIFICANT RESISTANCE TO FLUSH ATTEMPT. CATHETER DRESSING TAKEN DOWN FOR FARTHER EVALUATION. INSERTION SITE, SURROUNDING SKIN, AND CATHETER ALL APPEARING UNREMARKABLE. CATHETER STILL INTACT AND SECURE WITH SKIN GLUE AT 12 CM EASILY WITHDRAWN TO 10 CM, CONTINUED RESISTANCE TO FLUSH ATTEMPT AT INSERTION SITE AND FRACTURED TIP NOTED AT SKIN. REMAINDER COMPONENT OF CATHETER IS NOT PALPABLE ON EXAM AND INSERTION SITE APPEARS UNREMARKABLE. ESTIMATED LENGTH OF RETAINED CATHETER IS 8 CM.
Patient problems: Foreign Body In Patient
MAUDE report 23649452 ↗
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
- Extension Set41 models · 101 reports · 16 recalls
- Design Options116 models · 132 reports · 14 recalls
- Blood Administration Set24 models · 177 reports · 13 recalls
- Caresite23 models · 420 reports · 4 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.
How reports and recalls are matched · Editorial policy · Report an error on this page