Statlock ArterialRecalls & reported problems across all models

We found 3 models of Statlock Arterial by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 92 adverse event reports in the FDA's MAUDE database, received between Apr 7, 2017 and May 23, 2025 — classified as 9 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (46 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. 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

Most reported Statlock Arterial problems

Statlock Arterial models

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

• Statlock Arterial ART0420

  Set, administration, intravascular
  43 reports
• Statlock Arterial ART0220

  Set, administration, intravascular
  37 reports
• Statlock Arterial ART0421

  Set, administration, intravascular
  12 reports

Recent Statlock Arterial adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED RN NOTICED ALINE DRESSING WAS RED AND OOZY. RN NOTICED THAT THE CATHETER REMAINED IN THE PATIENT BUT IT WAS DISCONNECTED, WHICH CAUSED HIM TO BLEED EVEN WITH PRESSURE APPLIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22079498 ↗
• MalfunctionMay 15, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED WE HAD AN ARTERIAL LINE STATLOCK THAT SLID OFF OF THE END OF THE PRESSURE TUBING EXTENSION SET WHICH IS SUPPOSED TO BE KIND OF SODERED/ GLUED TOGETHER AND NOT SUPPOSED TO COME APART. THIS WAS IDENTIFIED QUICKLY, BUT BLOOD WAS FLOWING OUT FROM THE LINE AS IT WAS NO LONGER TIGHTLY CONNECTED. THE TOP LUER LOCK AREA (WHICH IS BLOODY) IS WHERE IT DISCONNECTED THE POOPED OFF PIECE IS RIGHT BELOW ITS NORMAL GLUED ATTACHMENT. THE NURSE PLACED AN ON POINT. ADDITIONAL INFORMATION: WHEN THE LINE POPPED APART THE HIGH ALARM WENT OFF AND THE NURSE WENT RIGHT IN. BLOOD WAS COMING OUT FROM THE OPEN ARTERIAL LINE BUT THE NURSE INTERVENED IMMEDIATELY TO STOP THE FLOW OF BLOOD. VISITORS WERE IN THE ROOM AND REPORTED THAT THE PATIENT WAS NOT MOVING OR DOING ANYTHING THAT MIGHT HAVE DISTURBED THE ARTERIAL LINE. PATIENT HARM WAS PREVENTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22031555 ↗
• MalfunctionOct 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE ARTERIAL LINE EXTENSION TUBING LEAKING WHEN CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533456 ↗
• MalfunctionSep 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH, "R RADIAL ARTERIAL LINE CONNECTION TUBING CRACKED WITHIN 30MIN OF ARTERIAL LINE BEING PLACED. EQUIPMENT MALFUNCTION RAPIDLY RECOGNIZE BY BEDSIDE RN; NO TITRATION OF VASOPRESSORS OR MEDICAL DECISION-MAKING WAS MADE BASED ON INCORRECT BP READING." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195445 ↗
• MalfunctionAug 21, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH "REGISTERED NURSE (RN) NOTICED ARTERIAL LINE WAVE FORM APPEARED FLAT ON MONITOR. RN ASSESSED THE ARTERIAL LINE AND NOTICED BLOOD COMING FROM THE J LOOP. THE LINES TEAM WAS CALLED TO ASSESS AND NOTED THE TUBING WAS CRACKED. THE TUBING WAS CHANGED. NO KNOWN PATIENT HARM AT THIS TIME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020169 ↗
• MalfunctionAug 14, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT "DEFECTIVE ARTERIAL LINE EXTENSION TUBING, LEAKING WHEN CONNECTED TO". NO ADVERSE EVENTS TO PATIENT, LINE SWITCHED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987963 ↗
• MalfunctionJul 26, 2024

  REGISTERED NURSE (RN) NOTICED ARTERIAL LINE WAVE FORM APPEARED FLAT ON MONITOR. RN ASSESSED THE ARTERIAL LINE AND NOTICED BLOOD COMING FROM THE J LOOP. THE LINES TEAM WAS CALLED TO ASSESS AND NOTED THE TUBING WAS CRACKED. THE TUBING WAS CHANGED. NO KNOWN PATIENT HARM AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19837400 ↗
• MalfunctionJul 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH, PATIENT WAS GETTING AN ARTERIAL LINE PLACED. WHEN THE CONNECTOR PIECE WAS ATTACHED, A CRACK OCCURRED AT THE CONNECTION. THIS RESULTED IN BLOOD AND FLUIDS COMING OUT OF THE CRACK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809413 ↗
• MalfunctionJul 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH, ARTERIAL LINE PLACED IN PATIENT, WHEN CONNECTOR TUBING ATTACHED, LEAKING BLOOD FROM TUBING AT CONNECTION SITE, AREA CRACKED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19809404 ↗
• MalfunctionJul 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER R RADIAL ARTERIAL LINE CONNECTION TUBING CRACKED WITHIN 30 MIN OF ARTERIAL LINE BEING PLACED. EQUIPMENT MALFUNCTION RAPIDLY RECOGNIZE BY BEDSIDE RN; NO TITRATION OF VASOPRESSORS OR MEDICAL DECISION MAKING WAS MADE BASED ON INCORRECT BP READING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19771800 ↗
• MalfunctionJul 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY MEDWATCH THAT A-LINE MONITORING EXTENSION SET (HIGH PRESSURE TUBE WITH ONE WAY STOPCOCK) HAD A CRACK/LEAKING. A-LINE TUBE WAS BEING REPLACED AND UPON ATTACHMENT OF NEW TUBING, THE EXTENSION WAS FOUND TO BE LEAKING. UNABLE TO PROPERLY FLUSH OR GET ACCURATE READINGS OF PATIENT'S BLOOD PRESSURE DUE TO LEAK IN HIGH PRESSURE EXTENSION TUBING. IT IS UNKNOWN IF ANY ADVERSE EVENT OCCURRED OR IF THERE WAS ANY PATIENT IMPACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657355 ↗
• MalfunctionJun 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH ARTERIAL LINE INSERTED, PA PROVIDER FLUSHED STATLOCK DEVICE WITH NO ISSUES. CONNECT PATIENT TO TRANSFER SET. AFTER FINISHING DRESSING NOTED TO HAVE BLOOD ON THE STERILE SITE. ARTERIAL LINE FLUSHED AND FLUID SPEWING FROM STABILIZATION EXTENSION SET. UPON INSPECTION TUBING NOTED TO BE CRACKED AND BLOOD BACKING BACK INTO SYSTEM. HAD TO BE CHANGED OUT. NO HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19641059 ↗
• MalfunctionJun 28, 2024Failure to Infuse; Contamination /Decontamination Problem; Failure to Infuse; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT WHEN INSERTING A-LINE AND CONNECTED TUBING, UNABLE TO FLUSH. WHEN YOU LOOK AT TUBING IN LIGHT YOU CAN SEE WHAT APPEARS TO BE AN EXTRA PIECE OF PLASTIC THAT IS CAUSING OBSTRUCTION. TWO DIFFERENT PROVIDERS EXPERIENCED THIS TODAY DURING THREE DIFFERENT CASES. NO OTHER INFORMATION WAS PROVIDED. THIS FILE ADDRESSES THE THIRD OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639838 ↗
• MalfunctionJun 28, 2024Failure to Infuse; Contamination /Decontamination Problem; Failure to Infuse; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT WHEN INSERTING A-LINE AND CONNECTED TUBING, UNABLE TO FLUSH. WHEN YOU LOOK AT TUBING IN LIGHT YOU CAN SEE WHAT APPEARS TO BE AN EXTRA PIECE OF PLASTIC THAT IS CAUSING OBSTRUCTION. TWO DIFFERENT PROVIDERS EXPERIENCED THIS TODAY DURING THREE DIFFERENT CASES. NO OTHER INFORMATION WAS PROVIDED. THIS FILE ADDRESSES THE SECOND OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639837 ↗
• MalfunctionJun 28, 2024Failure to Infuse; Contamination /Decontamination Problem; Failure to Infuse; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT WHEN INSERTING A-LINE AND CONNECTED TUBING, UNABLE TO FLUSH. WHEN YOU LOOK AT TUBING IN LIGHT YOU CAN SEE WHAT APPEARS TO BE AN EXTRA PIECE OF PLASTIC THAT IS CAUSING OBSTRUCTION. TWO DIFFERENT PROVIDERS EXPERIENCED THIS TODAY DURING THREE DIFFERENT CASES. NO OTHER INFORMATION WAS PROVIDED. THIS FILE ADDRESSES THE FIRST OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639831 ↗

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