Statlock Arterial ART0420Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00801741081354), received between Mar 4, 2020 and May 23, 2025 — classified as 8 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (18 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 25 most recent of 43 reports, 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 ↗
• MalfunctionJun 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH, "HUSBAND WAS HOLDING THE PATIENT'S HAND WHEN HE NOTED BLOOD LEAKING FROM THE A-LINE TUBING. DEFECT WAS NOTED 4 HOURS AFTER INSERTION. A-LINE WAS INSERTED AROUND 10PM BY MD. NO ISSUES NOTED DURING TUBING CHECK PRIOR TO INSERTION. BLOOD DRAWS WERE DONE AT 10:11PM AND 1:20AM POST INSERTION WITH NO ISSUES NOTED FROM THE A-LINE CONNECTOR. TWO RNS WERE AT BEDSIDE PERFORMING CARE WHEN PATIENT'S HUSBAND BROUGHT TO OUR ATTENTION AROUND 2AM THAT BLOOD WAS LEAKING FROM THE "IV". SLOW TRICKLE OF BLOOD NOTED FROM THE A-LINE CONNECTOR WHEN RN CHECKED IT. A-LINE ALARM DID NOT GO OFF DUE TO LEAKAGE WAS SLOW TRICKLE AND STILL GENERATING PRESSURES." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19590502 ↗
• InjuryJun 20, 2024Crack; Crack

  IT WAS REPORTED LEAKING STAT-LOCK ARTERIAL LINE DEVICE, NEWLY INSERTED ARTERIAL LINE STAT-LOCK DEVICE NOTED TO HAVE BLOOD BACKING UP AND LEAKING ON PILLOW, UPON SWITCHING TO NEW LINE, NOTED CRACK IN TUBING WHERE BLOOD WAS LEAKING FROM. PRODUCT ISSUE WITH CRACKING CAUSING BLOOD TO BACK UP INTO TUBING, INACCURATE BLOOD PRESSURE. SWITCHED TO NEW STAT-LOCK WITH NO ISSUES. NO OTHER INFORMATION WAS PROVIDED. 06/12/2024 - TWO ARTERIAL STATLOCKS WERE RETURNED FOR EVALUATION. THE LUER OF BOTH SAMPLES WERE CRACKED. THIS REPORT ADDRESSES THE SECOND SAMPLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19576094 ↗
• MalfunctionJun 14, 2024Defective Component; Defective Component

  IT WAS REPORTED THE EXTENSION TUBE FOUND IN ARTERIAL LINE INSERTION KITS UNABLE TO READ WAVEFORM, FLUSH, OR DRAW BACK BLOOD WHEN ATTACHED TO A-LINE TUBING AND TRANSDUCER. WHEN EXTENSION TUBING IS REMOVED AND A-LINE LINE TUBING CONNECTED DIRECTLY TO ARTERIAL LINE CATHETER WAVEFORM ABLE TO BE READ, FLUSHED, AND BLOOD CAN BE DRAWN BACK. X2 EXTENSION TUBING FROM 2 DIFFERENT KITS WITH SAME PROBLEM. A NEW ARTERIAL LINE NEEDED TO BE INSERTED, BUT NO PATIENT HARM REPORTED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536919 ↗
• MalfunctionJun 14, 2024Defective Component; Defective Component

  IT WAS REPORTED THE EXTENSION TUBE FOUND IN ARTERIAL LINE INSERTION KITS UNABLE TO READ WAVEFORM, FLUSH, OR DRAW BACK BLOOD WHEN ATTACHED TO A-LINE TUBING AND TRANSDUCER. WHEN EXTENSION TUBING IS REMOVED AND A-LINE LINE TUBING CONNECTED DIRECTLY TO ARTERIAL LINE CATHETER WAVEFORM ABLE TO BE READ, FLUSHED, AND BLOOD CAN BE DRAWN BACK. X2 EXTENSION TUBING FROM 2 DIFFERENT KITS WITH SAME PROBLEM. A NEW ARTERIAL LINE NEEDED TO BE INSERTED, BUT NO PATIENT HARM REPORTED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536750 ↗
• MalfunctionApr 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY MEDWATCH, "CRACKED STAT-LOCK DEVICE INSIDE ARTERIAL LINE INSERTION KIT. BACKGROUND: FOR ARTERIAL LINE PLACEMENT THERE IS AN INSERTION BUNDLE KIT THAT PROVIDERS USE THAT HAVE ALL ITEMS NEEDED FOR STERILE INSERTION. ASSESSMENT: BUNDLE KIT WAS USED, PRIOR TO ATTACHING STAT-LOCK IT WAS NOTED BY PROVIDER TO HAVE CRACKED PLASTIC ATTACHMENT. RECOMMENDATION: REVIEW PRODUCT INSIDE BUNDLE KIT--MADE BY BARD ITEM IDENTIFIED AS BARD ART0420 IN KIT ART685 IN CENTURION KIT ART685."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096351 ↗
• MalfunctionApr 11, 2024Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED VIA MEDWATCH ¿ALINE PREPARATION FOR PATIENT AND THE ACTUAL TUBING LEAKED AT THE ONE OF THE CONNECTIONS WHEN FLUSHED. ALINE REQUIRED FOR PATIENT IN ICU. PREPPED ALINE FOR INSERTION AND CONFIRMED LINE WAS FLUSHED RECOGNIZED SALINE LEAKAGE AT CONNECTION. NEW ALINE RETRIEVED AND INSERTED. ITEM IDENTIFIED AS ART0420 IN KIT ART685 IN CENTURION KIT ART685. TOLD THIS HAS HAPPENED (B)(4) OTHER TIMES THIS WEEK.¿ IT WAS REPORTED THIS EVENT OCCURRED A TOTAL (B)(4) TIMES. THIS REPORT ADDRESSES THE (B)(4) EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087755 ↗
• InjuryMar 8, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED LEAKING STAT-LOCK ARTERIAL LINE DEVICE, NEWLY INSERTED ARTERIAL LINE STAT-LOCK DEVICE NOTED TO HAVE BLOOD BACKING UP AND LEAKING ON PILLOW, UPON SWITCHING TO NEW LINE, NOTED CRACK IN TUBING WHERE BLOOD WAS LEAKING FROM. PRODUCT ISSUE WITH CRACKING CAUSING BLOOD TO BACK UP INTO TUBING, INACCURATE BLOOD PRESSURE. SWITCHED TO NEW STAT-LOCK WITH NO ISSUES. NO OTHER INFORMATION WAS PROVIDED. 06/12/2024 - TWO ARTERIAL STATLOCKS WERE RETURNED FOR EVALUATION. THE LUER OF BOTH SAMPLES WERE CRACKED. THIS REPORT ADDRESSES THE FIRST SAMPLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18870571 ↗
• InjuryMar 1, 2024Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THE PRODUCT IS CRACKED. IT APPEARS TO BE THE EXTENSION TUBING ITSELF WHICH WOULD BE DIFFERENT THAN THE STATLOCK DEVICES WHICH WOULD GO OVER THE TUBING AND HUB. LEAKING STAT-LOCK ARTERIAL LINE DEVICE. NEWLY INSERTED ARTERIAL LINE STAT-LOCK DEVICE NOTED TO HAVE BLOOD BACKING UP AND LEAKING ON PILLOW. UPON SWITCHING TO NEW LINE, NOTED CRACK IN TUBING WHERE BLOOD WAS LEAKING FROM. PRODUCT ISSUE WITH CRACKING CAUSING BLOOD TO BACK UP INTO TUBING, INACCURATE BLOOD PRESSURE, SWITCHED TO NEW STAT-LOCK WITH NO ISSUES. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. ONE DEVICE WAS USED ON A PATIENT AND ONE WAS NOT USED ON A PATIENT. THIS REPORT ADDRESSES THE DEVICE THAT WAS NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822024 ↗
• InjuryMar 1, 2024Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THE PRODUCT IS CRACKED. IT APPEARS TO BE THE EXTENSION TUBING ITSELF WHICH WOULD BE DIFFERENT THAN THE STATLOCK DEVICES WHICH WOULD GO OVER THE TUBING AND HUB. LEAKING STAT-LOCK ARTERIAL LINE DEVICE. NEWLY INSERTED ARTERIAL LINE STAT-LOCK DEVICE NOTED TO HAVE BLOOD BACKING UP AND LEAKING ON PILLOW. UPON SWITCHING TO NEW LINE, NOTED CRACK IN TUBING WHERE BLOOD WAS LEAKING FROM. PRODUCT ISSUE WITH CRACKING CAUSING BLOOD TO BACK UP INTO TUBING, INACCURATE BLOOD PRESSURE, SWITCHED TO NEW STAT-LOCK WITH NO ISSUES. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. ONE DEVICE WAS USED ON A PATIENT AND ONE WAS NOT USED ON A PATIENT. THIS REPORT ADDRESSES THE DEVICE THAT WAS USED ON A PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18822017 ↗
• MalfunctionJul 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT HAD 5 INSTANCES OF THE CONNECTION BREAKING OFF CAUSING A CONSIDERABLE AMOUNT OF BLOOD LOSS TO THE PATIENT. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: Exsanguination

  MAUDE report 17262609 ↗