INTROCAN SAFETYRecalls & reported problems across all models
B. Braun Medical Inc. · 46 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one INTROCAN SAFETY model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 316
- Deaths reported
- 1
- Injuries reported
- 43
- Recalls
- 1
We found 46 models of INTROCAN SAFETY by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 316 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2016 and Jun 19, 2026 — classified as 1 death, 43 injuries, 272 malfunctions.
The most frequently reported specific device problem is “Break” (90 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
INTROCAN SAFETY 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 1, 2022Open, Classified
Potential for leakage at the catheter hub.
Z-0009-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported INTROCAN SAFETY problems
Device problems
- Break90
- Fail-Safe Problem67
- Leak/Splash35
- Contamination /Decontamination Problem31
- Fluid/Blood Leak29
- Protective Measures Problem27
- Positioning Problem10
- Detachment of Device or Device Component9
Patient problems
- No Clinical Signs, Symptoms or Conditions117
- Needle Stick/Puncture59
- Foreign Body In Patient51
- No Known Impact Or Consequence To Patient39
- No Consequences Or Impact To Patient14
- Device Embedded In Tissue or Plaque12
- Vasculitis11
- Pain4
INTROCAN SAFETY models
46 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INTROCAN SAFETY® 4251890-02INTRODUCER, CATHETER1 recall2 reports
- INTROCAN SAFETY® 4251652-02Catheter,intravascular,therapeutic,short-term less than 30 days33 reports
- INTROCAN SAFETY® 4251601-020Catheter,intravascular,therapeutic,short-term less than 30 days32 reports
- INTROCAN SAFETY® 4252535-02Catheter,intravascular,therapeutic,short-term less than 30 days26 reports
- INTROCAN SAFETY® 4251644-02Catheter,intravascular,therapeutic,short-term less than 30 days23 reports
- INTROCAN SAFETY® 4251628-02INTRODUCER, CATHETER23 reports
- INTROCAN SAFETY® 4252500-02INTRODUCER, CATHETER19 reports
- INTROCAN SAFETY® 4252519-02Catheter,intravascular,therapeutic,short-term less than 30 days18 reports
- INTROCAN SAFETY® 4252543-02INTRODUCER, CATHETER14 reports
- INTROCAN SAFETY® 4251687-02INTRODUCER, CATHETER11 reports
- INTROCAN SAFETY® 4251628-020INTRODUCER, CATHETER11 reports
- INTROCAN SAFETY® 4251601-02INTRODUCER, CATHETER10 reports
- INTROCAN SAFETY® 4252560-02Catheter,intravascular,therapeutic,short-term less than 30 days8 reports
- INTROCAN SAFETY® 4252527-02Catheter,intravascular,therapeutic,short-term less than 30 days8 reports
- INTROCAN SAFETY® 4254503-02INTRODUCER, CATHETER8 reports
- INTROCAN SAFETY® 4251644-020INTRODUCER, CATHETER1 death8 reports
- INTROCAN SAFETY® 4252520-02Catheter,intravascular,therapeutic,short-term less than 30 days7 reports
- INTROCAN SAFETY® 4253540-02INTRODUCER, CATHETER4 reports
- INTROCAN SAFETY® 4251621-02Catheter,intravascular,therapeutic,short-term less than 30 days4 reports
- INTROCAN SAFETY® 4251611-02INTRODUCER, CATHETER3 reports
- INTROCAN SAFETY® 4252511-02Catheter,intravascular,therapeutic,short-term less than 30 days3 reports
- INTROCAN SAFETY® 4252551-02INTRODUCER, CATHETER3 reports
- INTROCAN SAFETY® 4252586-02INTRODUCER, CATHETER3 reports
- INTROCAN SAFETY® 4253523-02INTRODUCER, CATHETER3 reports
- INTROCAN SAFETY® 4253566-02INTRODUCER, CATHETER3 reports
- INTROCAN SAFETY® 4252561-02INTRODUCER, CATHETER3 reports
- INTROCAN SAFETY® 4252520-020Catheter,intravascular,therapeutic,short-term less than 30 days3 reports
- INTROCAN SAFETY® 4251622-02Catheter,intravascular,therapeutic,short-term less than 30 days3 reports
- INTROCAN SAFETY® 4253574-02Catheter,intravascular,therapeutic,short-term less than 30 days2 reports
- INTROCAN SAFETY® 4254562-020INTRODUCER, CATHETER2 reports
- INTROCAN SAFETY® 4254511-02Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- INTROCAN SAFETY® 4251717-02INTRODUCER, CATHETER1 report
- INTROCAN SAFETY® 4251679-02INTRODUCER, CATHETER1 report
- INTROCAN SAFETY® 4253511-02INTRODUCER, CATHETER1 report
- INTROCAN SAFETY® 4254562-02INTRODUCER, CATHETER1 report
- INTROCAN SAFETY® 4251717-020Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- INTROCAN SAFETY® 4251687-020Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- INTROCAN SAFETY® 4252560-020INTRODUCER, CATHETER1 report
- INTROCAN SAFETY® 4252543-020Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- INTROCAN SAFETY® 4252535-020INTRODUCER, CATHETER1 report
- INTROCAN SAFETY® 4254538-020INTRODUCER, CATHETER1 report
- INTROCAN SAFETY® 4252527-020Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- INTROCAN SAFETY® 4252519-020Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- INTROCAN SAFETY® 4252500-020INTRODUCER, CATHETER1 report
- INTROCAN SAFETY® 4252594-020INTRODUCER, CATHETER1 report
- INTROCAN SAFETY® 4251620-02INTRODUCER, CATHETER1 report
Recent INTROCAN SAFETY adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 19, 2026Break
AS REPORTED IN THE MEDSUN (B)(4). DESCRIBE THE EVENT OR PROBLEM: PT CONSENTED FOR A CAUDAL BLOCK PRIOR TO CHORDEE CORRECTION AND CIRCUMCISION WITH DR. 1 [REDACTED]. AFTER THE BLOCK TIMEOUT AND PREPPING, DR. 2 [REDACTED] STARTED THE CAUDAL BLOCK WITH DR. 3 [REDACTED] BY HER SIDE. CAUDAL ATTEMPTED WITH A 20G CATHETER. ATTEMPT WAS UNSUCCESSFUL AND NEEDLE WITH CATHETER MET RESISTANCE UPON REMOVING. WHEN REMOVING THE IV CATHETER, THE NEEDLE WAS FULLY INTACT, BUT 1.5CM OF THE IV CATHETER WAS MISSING FROM THE CATHETER PULLED OUT. WHAT WAS LEFT OF THE CATHETER WAS FRAYED AT THE END. DR. 3 [REDACTED] DID AN ULTRASOUND IN THE OR AND SAW THE CATHETER LEFT BEHIND SUBCUTANEOUSLY. CARE TEAM MEMBER REACHED OUT TO GENERAL SURGERY MD. DR. 1 [REDACTED] SPOKE WITH IR [INTERVENTIONAL RADIOLOGY] AND PLACED AN ORDER FOR ULTRASOUND IMAGING TO CONFIRM THE LOCATION IS SUBCUTANEOUS. CARE TEAMS CONFIRMED SUBCUTANEOUS LOCATION OF THE 1.3CM CATHETER. FAMILY HAD BEEN NOTIFIED THAT AN ULTRASOUND ORDER WAS PLACED AND WENT TO THE FRONT DESK CONCERNED. FAMILY PLACED IN CONSULT ROOM FOR DR. 1 [REDACTED] TO INFORM THEM OF THE SITUATION. GENERAL SURGERY MD CONSENTED THE FAMILY TO REMOVE THE CATHETER. CATHETER WAS A 20
Patient problems: Foreign Body In Patient
MAUDE report 25563575 ↗InjuryJun 19, 2026Break
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: "IV WAS STARTED IN ER ON (B)(6) 2023. UNSURE OF LOT NUMBER; HOWEVER, WE BELIEVE IT WAS A BRAUN BRAND 18-GAUGE CATHETER 1 3/4 INCH." DETAILED INQUIRY DESCRIPTION: "IT WAS REPORTED THAT ON (B)(6) 2023 A 18GA 1.75IN IV CATHETER BROKE IN A PATIENTS ARM WHILE BEING REMOVED. THE PATIENT HAD TO BE TRANSPORTED TO SURGERY TO HAVE THE DEVICE REMOVED. AS PART OF AN INTERNAL NONCONFORMANCE, THIS IMPORTER MDR IS BEING SUBMITTED RETROACTIVELY. PLEASE NOTE THAT THE ASSOCIATED MANUFACTURER MDR FOR THIS EVENT, 9610825-2023-00614, HAD ALREADY BEEN PREVIOUSLY SUBMITTED TIMELY ON 18DEC2023. AS B. BRAUN MEDICAL, INC. SUBMITTED THE MANUFACTURER MDR ON BEHALF OF THE MANUFACTURER, THE IMPORTER MDR WAS INADVERTENTLY MISSED.
Patient problems: Foreign Body In Patient
MAUDE report 25563496 ↗InjuryJun 19, 2026Break
AS REPORTED BY THE USER FACILITY: CATHETER BROKEN OFF. DESCRIPTION - PIECE OF THE CATHETER BROKE OFF IN THE PATIENTS ARM AND HAD BEEN SURGICALLY REMOVED. PATIENT WAS ADMITTED TO THE HOSPITAL (B)(6) 2023 WHICH IV WAS STARTED. ON (B)(6) 2023 IV WAS REMOVED ONCE PATIENT WAS RELEASED FROM HOSPITAL, HE WAS SENT HOME AND THE PLACE THE IV WAS GOT INFECTED. THEY HAD AN ULTRASOUND DONE AND FOUND A PIECE OF THE CATHETER IN HIS BASILIC VEIN (RIGHT ARM). ON (B)(6) 2023 SURGERY WAS PERFORMED TO REMOVE THE BROKEN PIECE. PATIENT WAS OKAY. MALE 61 UNABLE TO VERIFY WHICH CATHETER BROKE OFF. PART NUMBERS LISTED ARE 4252527-02 & 4251652-02 IN PATIENT RECORD. AS PART OF AN INTERNAL NONCONFORMANCE, THIS IMPORTER MDR IS BEING SUBMITTED RETROACTIVELY. PLEASE NOTE THAT THE ASSOCIATED MANUFACTURER MDR FOR THIS EVENT, 9610825-2023-00612, HAD ALREADY BEEN PREVIOUSLY SUBMITTED TIMELY ON 18DEC2023. AS B. BRAUN MEDICAL, INC. SUBMITTED THE MANUFACTURER MDR ON BEHALF OF THE MANUFACTURER, THE IMPORTER MDR WAS INADVERTENTLY MISSED.
Patient problems: Foreign Body In Patient; Unspecified Infection
MAUDE report 25563378 ↗InjuryJun 19, 2026Break
AS REPORTED BY THE USER FACILITY: INTROCAN CATHETER CANNULA SEPARATED. CUSTOMER EXPERIENCED AN ISSUE WITH A RETAINED PORTION OF THE CATHETER IN A PATIENT. AS PART OF AN INTERNAL NONCONFORMANCE, THIS IMPORTER MDR IS BEING SUBMITTED RETROACTIVELY. PLEASE NOTE THAT THE ASSOCIATED MANUFACTURER MDR FOR THIS EVENT, 9610825-2022-00062, HAD ALREADY BEEN PREVIOUSLY SUBMITTED TIMELY ON 08MAR2022. AS B. BRAUN MEDICAL, INC. SUBMITTED THE MANUFACTURER MDR ON BEHALF OF THE MANUFACTURER, THE IMPORTER MDR WAS INADVERTENTLY MISSED.
Patient problems: Foreign Body In Patient; Needle Stick/Puncture
MAUDE report 25562090 ↗InjuryJun 17, 2026Break
AS REPORTED ON MW (B)(4): 22G IV CATHETER BROKE UPON ATTEMPTED IV REMOVAL. THE CLEAR CATHETER PORTION BROKE APART FROM THE BLUE HUB. THE PATIENT WAS TAKEN TO THE IR LAB FOR RETAINED FOREIGN BODY RETRIEVAL. THE FOREIGN BODY WAS REMOVED COMPLETELY. BEDSIDE RN REMOVED DRESSING ON RT FOREARM PIV TO ASSESS LEAKING, NOTED THAT HUB BROKE OFF FROM CATHETER, AND CATHETER APPEARS TO BE RETAINED IN THE BODY. RN CALLED VAD TO ASSESS. VAD ASKED RN TO APPLY TOURNIQUET TO RT UPPER ARM, IMMEDIATELY CAME TO BEDSIDE. PT IS CALM, NO DISTRESS. VAD CAN SEE CATHETER FRAGMENT ON US RETAINED IN LOWER RT FOREARM CEPHALIC VEIN; I MARKED LOCATION WITH STERILE SKIN PEN. THIS VAD RN REMAINED AT BEDSIDE, CONTINUOUSLY MONITORING PT, KEPT TOURNIQUET ON RT UPPER ARM, APPLIED HAND TOURNIQUET TO UPPER FOREARM, PERIODICALLY CHECKED THAT CATHETER PIECE REMAINED IN SAME PLACE ON US, ENSURED THAT PT KEPT RT ARM STILL/RELAXED AND DID NOT GET OUT OF BED, HAD PT CALL HER MOM SO I COULD UPDATE HER AND ASK HER TO COME BACK TO THE HOSPITAL. COVERING MDS (INTERN, FELLOW, ATTENDING) CAME TO BEDSIDE TO ASSESS AND UPDATE, STATE IR TEAM WILL COME IN EMERGENTLY TO REMOVE CATHETER FRAGMENT. THIS VAD RN REMAINED AT BEDSIDE CONTINUOUS
Patient problems: Foreign Body In Patient
MAUDE report 25536938 ↗InjuryMay 13, 2026Break
AS REPORTED ON MEDWATCH REPORT # MW5186242: DESCRIBE EVENT OR PROBLEM: PATIENTS' IV HUB WAS FOUND IN HIS BED WITHOUT IV CATHETER ATTACHED TO THE HUB. THE CATHETER WAS PALPABLE IN THE PATIENTS LEFT UPPER ARM AND UNABLE TO BE REMOVED MANUALLY. ULTRASOUND IDENTIFIED THE CATHETER TO STILL BE IN THE CEPHALIC VEIN. VASCULAR SURGERY RECOMMENDS CONSERVATIVE MANAGEMENT DUE TO THE PATIENTS AGE AND COMORBIDITIES, SO 81MG OF ASPIRIN WAS STARTED DAILY.
Patient problems: Foreign Body In Patient
MAUDE report 25164887 ↗InjuryMay 13, 2026Break
AS REPORTED ON MEDWATCH REPORT # MW5186242: DESCRIBE EVENT OR PROBLEM: PATIENTS' IV HUB WAS FOUND IN HIS BED WITHOUT IV CATHETER ATTACHED TO THE HUB. THE CATHETER WAS PALPABLE IN THE PATIENTS LEFT UPPER ARM AND UNABLE TO BE REMOVED MANUALLY. ULTRASOUND IDENTIFIED THE CATHETER TO STILL BE IN THE CEPHALIC VEIN. VASCULAR SURGERY RECOMMENDS CONSERVATIVE MANAGEMENT DUE TO THE PATIENTS AGE AND COMORBIDITIES, SO 81MG OF ASPIRIN WAS STARTED DAILY.
Patient problems: Foreign Body In Patient
MAUDE report 25164886 ↗MalfunctionApr 21, 2026Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY: DESCRIBE THE EVENT OR PROBLEM: NO HARM TO PATIENT. UPON PIV [PERIPHERAL IV] PLACEMENT, METAL NEEDLE DISLODGED FROM FLASH CHAMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24938374 ↗MalfunctionMar 30, 2026Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: PERIPHERAL IV PLACED AND SAFETY MECHANISM TO SHIELD NEEDLE DID NOT RETRACT UPON NEEDLE WITHDRAWAL, EXPOSING THE NEEDLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715266 ↗MalfunctionMar 24, 2026Break; Difficult to Advance; Material Deformation
THE COMPLAINANT REPORTED THAT A 22 GAUGE PERIPHERAL INTRAVENOUS LINE (PIV) CATHETER WAS PLACED WITH CONFIRMED BLOOD RETURN. BLOOD WAS SUCCESSFULLY OBTAINED FOR LABORATORY TESTING AT THE TIME OF PLACEMENT. UPON FLUSHING THE CATHETER FOLLOWING BLOOD COLLECTION, RESISTANCE WAS ENCOUNTERED; HOWEVER, BLOOD RETURN REMAINED VISIBLE. THE TRANSPARENT DRESSING WAS REMOVED TO BETTER ASSESS THE INSERTION SITE. THE PIV SITE WAS NOTED TO BE TENDER, AND THE VEIN APPEARED COMPROMISED ("BLOWN"). THE CATHETER WAS REMOVED. UPON INSPECTION, THE CATHETER TIP APPEARED FRAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24681115 ↗MalfunctionMar 19, 2026Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: NURSE STATED - WHEN SHE PULLED THE CATHETER OUT, SHE NOTICED THE PASSIVE SAFETY SHIELD WAS NOT SECURE ON THE TOP OF THE CATHETER AND THE NEEDLE TIP WAS EXPOSED. SHE SAID THE PASSIVE SAFETY SHIELD WAS MOVING UP AND DOWN THE CATHETER. PHOTO UPLOADED IN FILES SECTION. PATIENT INJURY: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637388 ↗MalfunctionFeb 11, 2026Break
AS REPORTED BY THE USER FACILITY: ISSUE: PLASTIC PORTION THAT REMAINS IN THE VEIN IS FRYING. SPLIT DOWN THE MIDDLE AND OPENED. PATIENT INJURY NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317668 ↗MalfunctionJan 22, 2026Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: CUSTOMER STATES SAFETY SHIELD FAILED TO ENGAGE. PATIENT INJURY NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24152606 ↗MalfunctionDec 23, 2025Break; Break
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: INTROCAN IV CATHETER 4251687-02 FAILED DURING THERAPY. CATHETER BROKE OFF FROM HUB UPON REMOVAL; CATHETER PIECE REMAINS INSIDE PATIENT AND WILL BE EVALUATED BY A VASULAR SURGEON TODAY.
Patient problems: Foreign Body In Patient
MAUDE report 23878188 ↗MalfunctionDec 19, 2025Fail-Safe Problem; Device Handling Problem; Fail-Safe Problem; Device Handling Problem
AS REPORTED BY THE USER FACILITY: DURING THERAPY THE IV CATHETER SAFETY SHIELD DID NOT DEPLOY. CLINICIAN WAS POKED WITH A DIRTY NEEDLE.
Patient problems: Needle Stick/Puncture
MAUDE report 23854838 ↗
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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