INTROCAN SAFETY® 4252543-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04046963185190), received between Dec 2, 2016 and May 13, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 reports).

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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionNov 26, 2025Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: IV CATHETER STICK BECAUSE SAFETY MECHANISM FAILED. PATIENT INJURY: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656064 ↗
• MalfunctionNov 29, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: REPORTED ISSUE PER CUSTOMER: "RECENTLY THERE HAVE BEEN COMPLAINTS THAT EVEN WHEN TIGHTENING THE IV CATHETER TO THE IV TUBING THERE IS LEAKING OF THE FLUIDS, BLOOD, AND EVEN THE MEDS FOR SEDATION." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18233926 ↗
• MalfunctionNov 29, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: REPORTED ISSUE PER CUSTOMER: "RECENTLY THERE HAVE BEEN COMPLAINTS THAT EVEN WHEN TIGHTENING THE IV CATHETER TO THE IV TUBING THERE IS LEAKING OF THE FLUIDS, BLOOD, AND EVEN THE MEDS FOR SEDATION." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18233789 ↗
• MalfunctionOct 13, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: REPORTED ISSUE PER CUSTOMER: "RECENTLY THERE HAVE BEEN COMPLAINTS THAT EVEN WHEN TIGHTENING THE IV CATHETER TO THE IV TUBING THERE IS LEAKING OF THE FLUIDS, BLOOD, AND EVEN THE MEDS FOR SEDATION." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17929668 ↗
• MalfunctionOct 13, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: REPORTED ISSUE PER CUSTOMER: "RECENTLY THERE HAVE BEEN COMPLAINTS THAT EVEN WHEN TIGHTENING THE IV CATHETER TO THE IV TUBING THERE IS LEAKING OF THE FLUIDS, BLOOD, AND EVEN THE MEDS FOR SEDATION." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17929667 ↗
• MalfunctionDec 13, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: IV BROKE OFF IN PTS ARM WHEN REMOVING THE IV. THE PATIENT WAS REFERRED TO A VASCULAR SURGEON AND THE DECISION WAS MAD AT THIS TIME TO LEAVE THE FRAGMENT IN PLACE. IT WAS ALSO REPORTED BY THE RN THAT THERE WAS A SMALL PIECE OF PLASTIC CATHETER CLOSE TO THE HUB BUT THE REST WAS IN THE PATIENTS ARM 2 CM FRAGMENT CONFIRMED VIA ULTRASOUND, SENT FOR FOLLOW-UP WITH VASCULAR SURGEON FOR EXCISION AND/OR MANAGEMENT. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15971841 ↗
• MalfunctionMay 14, 2021Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  AS REPORTED BY THE USER FACILITY: AFTER 20G INTROCAN STICK AND BLOOD RETURN, UPON THREADING AND REMOVAL OF NEEDLE CATHETER WAS LEAKING BLOOD. PULLED IV AND APPEARED TO BE A HOLE OR TEAR IN IV CATHETER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11824442 ↗
• MalfunctionFeb 5, 2020Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: THE SAFETY FEATURE FAILED TO ACTIVATE AFTER USE ON A PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9673548 ↗
• MalfunctionJul 27, 2018Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: THE SAFETY DEVICE DID NOT ENGAGE ON THE IV CATHETER. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7726068 ↗
• MalfunctionAug 25, 2017Fail-Safe Design Failure; Fail-Safe Design Failure

  AS REPORTED BY USER FACILITY: SAFETY FEATURE DID NOT ENGAGE WHEN NEEDLE WAS TAKEN OUT. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6820071 ↗
• MalfunctionDec 2, 2016Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER STATED, "METAL PULLED APART WHEN BACKING OUT." LIMITED INFORMATION PROVIDED. NO INJURY. NO SAMPLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6140758 ↗