Statlock Arterial ART0220Recalls & reported problems
Bard Access Systems, Inc. · StatLock Arterial Plus crescent tricot bnd stopcock alc prep 25 box · Class 2
All models of Statlock Arterial (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Bard StatLock Arterial Plus is a secured catheter dressing set used to hold arterial lines in place. The 37 reports mostly describe leaking or blood leaking at the tubing connection where it joins the StatLock, along with parts breaking or coming loose, in some cases with bleeding or blood loss. There are no deaths and 1 injury. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741081279), received between Apr 7, 2017 and Feb 16, 2024 — classified as 1 injury, 36 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (22 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak22
- Break8
- Detachment of Device or Device Component7
- Defective Component2
- Misassembled2
- Detachment Of Device Component1
- Material Separation1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Hemorrhage/Blood Loss/Bleeding11
- Exsanguination2
- No Consequences Or Impact To Patient2
- Blood Loss1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT LEAKAGE AT TUBING BONDED SITE. DISCONNECTION OF TUBING SITE CONNECTED TO STATLOCK. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THIRTEEN DEVICES. THIS REPORT ADDRESSES THE FIFTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18725440 ↗MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT LEAKAGE AT TUBING BONDED SITE. DISCONNECTION OF TUBING SITE CONNECTED TO STATLOCK. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THIRTEEN DEVICES. THIS REPORT ADDRESSES THE THIRTEENTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18725430 ↗MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT LEAKAGE AT TUBING BONDED SITE. DISCONNECTION OF TUBING SITE CONNECTED TO STATLOCK. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THIRTEEN DEVICES. THIS REPORT ADDRESSES THE SEVENTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18725425 ↗MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT LEAKAGE AT TUBING BONDED SITE. DISCONNECTION OF TUBING SITE CONNECTED TO STATLOCK. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THIRTEEN DEVICES. THIS REPORT ADDRESSES THE TENTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18725423 ↗MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT LEAKAGE AT TUBING BONDED SITE. DISCONNECTION OF TUBING SITE CONNECTED TO STATLOCK. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THIRTEEN DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18725420 ↗MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT LEAKAGE AT TUBING BONDED SITE. DISCONNECTION OF TUBING SITE CONNECTED TO STATLOCK. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THIRTEEN DEVICES. THIS REPORT ADDRESSES THE TWELFTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18725417 ↗MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT LEAKAGE AT TUBING BONDED SITE. DISCONNECTION OF TUBING SITE CONNECTED TO STATLOCK. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THIRTEEN DEVICES. THIS REPORT ADDRESSES THE SIXTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18725412 ↗MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT LEAKAGE AT TUBING BONDED SITE. DISCONNECTION OF TUBING SITE CONNECTED TO STATLOCK. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THIRTEEN DEVICES. THIS REPORT ADDRESSES THE EIGHTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18725382 ↗MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT LEAKAGE AT TUBING BONDED SITE. DISCONNECTION OF TUBING SITE CONNECTED TO STATLOCK. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THIRTEEN DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18725379 ↗MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT LEAKAGE AT TUBING BONDED SITE. DISCONNECTION OF TUBING SITE CONNECTED TO STATLOCK. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THIRTEEN DEVICES. THIS REPORT ADDRESSES THE ELEVENTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18725370 ↗MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT LEAKAGE AT TUBING BONDED SITE. DISCONNECTION OF TUBING SITE CONNECTED TO STATLOCK. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THIRTEEN DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18725360 ↗MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT LEAKAGE AT TUBING BONDED SITE. DISCONNECTION OF TUBING SITE CONNECTED TO STATLOCK. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THIRTEEN DEVICES. THIS REPORT ADDRESSES THE NINTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18725340 ↗MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT LEAKAGE AT TUBING BONDED SITE. DISCONNECTION OF TUBING SITE CONNECTED TO STATLOCK. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THIRTEEN DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18725337 ↗MalfunctionDec 6, 2023Break; Break
IT WAS REPORTED BY THE CUSTOMER THAT ARTERIAL LINE ALARMED AND FOUND A-LINE EXTENSION TUBING SPONTANEOUSLY BROKE AT THE PATIENT END CONNECTOR TO THE INSERTION CATHETER WITH SIGNIFICANT BLEEDING RESULTING IN LOSS OF ARTERIAL LINE AND PRESSURE DRESSING APPLIED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18279450 ↗MalfunctionNov 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER THAT PT A-LINE EXTENSION TUBING SPONTANEOUSLY BROKE AT THE PATIENT END CONNECTOR TO THE INSERTION CATHETER WITH SIGNIFICANT BLEEDING.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18243775 ↗MalfunctionNov 22, 2023Break; Break
IT WAS REPORTED BY CUSTOMER THAT PATIENT'S A-LINE EXTENSION TUBING SPONTANEOUSLY BROKE AT THE PATIENT END CONNECTOR TO THE INSERTION CATHETER WITH SIGNIFICANT BLEEDING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18192808 ↗MalfunctionOct 20, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED BY CUSTOMER THAT THE ARTERIAL LINE EXTENSION TUBING SPONTANEOUSLY BROKE AT THE PATIENT END CONNECTOR TO THE INSERTION CATHETER. REQUIRED MANUAL COMPRESSION TO MANAGE BLEEDING FORM THE BROKEN LINE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17981549 ↗MalfunctionOct 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT PATIENT REPORTED BLEEDING AT ARTERIAL LINE SITE. ARTERIAL LINE EXTENSION TUBING SPONTANEOUSLY BROKE AT THE PATIENT END CONNECTOR TO THE INSERTION CATHETER. PATIENT HAD SIGNIFICANT BLEEDING AND ARTERIAL LINE HAD TO BE REMOVED.
Patient problems: Exsanguination
MAUDE report 17975697 ↗MalfunctionSep 22, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT THE ARTERIAL STATLOCK EXTENSION TUBING SPONTANEOUSLY BREAKING. ADDITIONAL INFORMATION 9/15 : WE HAVE REVIEWED AND IN EVERY CASE, IT IS THE SAME REPORTED COMPLAINT ¿ THE EXTENSION TUBING SPONTANEOUSLY BREAKS. SINCE THIS IS AN ARTERIAL LINE WHICH IS NEEDED TO MONITOR AND TREAT CRITICALLY ILL ICU PATIENTS, THERE IS A SIGNIFICANT BLEEDING RISK TO THE PATIENT. WITH THESE TUBING BREAKS, PATIENTS HAVE BEEN FOUND BLEEDING, HAD BLOOD LOSS, DELAY IN TREATMENT DUE TO NEEDING TO OBTAIN AND REPLACE HEMODYNAMIC TUBING AND/OR INSERT A NEW ARTERIAL LINE. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE NOR RELEVANT FOR THESE CASES. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17799212 ↗MalfunctionSep 22, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT THE ARTERIAL STATLOCK EXTENSION TUBING SPONTANEOUSLY BREAKING. ADDITIONAL INFORMATION 9/15 : WE HAVE REVIEWED AND IN EVERY CASE, IT IS THE SAME REPORTED COMPLAINT ¿ THE EXTENSION TUBING SPONTANEOUSLY BREAKS. SINCE THIS IS AN ARTERIAL LINE WHICH IS NEEDED TO MONITOR AND TREAT CRITICALLY ILL ICU PATIENTS, THERE IS A SIGNIFICANT BLEEDING RISK TO THE PATIENT. WITH THESE TUBING BREAKS, PATIENTS HAVE BEEN FOUND BLEEDING, HAD BLOOD LOSS, DELAY IN TREATMENT DUE TO NEEDING TO OBTAIN AND REPLACE HEMODYNAMIC TUBING AND/OR INSERT A NEW ARTERIAL LINE. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE NOR RELEVANT FOR THESE CASES. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17799211 ↗MalfunctionSep 22, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT THE ARTERIAL STATLOCK EXTENSION TUBING SPONTANEOUSLY BREAKING. ADDITIONAL INFORMATION 9/15: WE HAVE REVIEWED AND IN EVERY CASE, IT IS THE SAME REPORTED COMPLAINT ¿ THE EXTENSION TUBING SPONTANEOUSLY BREAKS. SINCE THIS IS AN ARTERIAL LINE WHICH IS NEEDED TO MONITOR AND TREAT CRITICALLY ILL ICU PATIENTS, THERE IS A SIGNIFICANT BLEEDING RISK TO THE PATIENT. WITH THESE TUBING BREAKS, PATIENTS HAVE BEEN FOUND BLEEDING, HAD BLOOD LOSS, DELAY IN TREATMENT DUE TO NEEDING TO OBTAIN AND REPLACE HEMODYNAMIC TUBING AND/OR INSERT A NEW ARTERIAL LINE. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE NOR RELEVANT FOR THESE CASES. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17799208 ↗MalfunctionSep 22, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT THE ARTERIAL STATLOCK EXTENSION TUBING SPONTANEOUSLY BREAKING. ADDITIONAL INFORMATION 9/15 : WE HAVE REVIEWED AND IN EVERY CASE, IT IS THE SAME REPORTED COMPLAINT ¿ THE EXTENSION TUBING SPONTANEOUSLY BREAKS. SINCE THIS IS AN ARTERIAL LINE WHICH IS NEEDED TO MONITOR AND TREAT CRITICALLY ILL ICU PATIENTS, THERE IS A SIGNIFICANT BLEEDING RISK TO THE PATIENT. WITH THESE TUBING BREAKS, PATIENTS HAVE BEEN FOUND BLEEDING, HAD BLOOD LOSS, DELAY IN TREATMENT DUE TO NEEDING TO OBTAIN AND REPLACE HEMODYNAMIC TUBING AND/OR INSERT A NEW ARTERIAL LINE. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE NOR RELEVANT FOR THESE CASES. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17799204 ↗MalfunctionAug 9, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER THAT PATIENT HAS A RIGHT RADIAL ALINE. ALINE SEPARATED FROM THE HUB CONNECTION OF THE STAT LOCK EXTENSION. THE TUBING SHOULD BE SEAL CONNECTED BUT THE TUBING CAME APART. ALINE WAS PLACED ON (B)(4) 2023 IN THE OR. THE STAT LOCK COULD BE FROM THE ALINE KIT. PATIENT HAD A BLOOD LOSS WHILE ATTEMPTING TO DISCERN THE AREA OF LEAKING AND DISCONNECTION. THE EVENT DID NOT INVOLVE A LIFE-THREATENING OR URGENT MEDICAL SITUATION.
Patient problems: Exsanguination; No Clinical Signs, Symptoms or Conditions
MAUDE report 17491676 ↗MalfunctionAug 8, 2023Defective Component; Defective Component
IT WAS REPORTED "CR BARD ARTERIAL STATLOCK. ARTERIAL STATLOCK EXTENSION TUBING SPONTANEOUSLY TORE AT THE PATIENT END. THE PATIENT HAD BEEN PULLING ON ART LINE BEFORE THIS. EVENT WAS CAUGHT BY RN AND NO HARM TO PATIENT OCCURRED. EVENT DID NOT INTERRUPT THE ADMINISTRATION OF ANY MEDICATION, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION, THAT NEGATIVELY IMPACTED THE PATIENT. TUBING WAS NOT SAVED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17481456 ↗MalfunctionAug 8, 2023Defective Component; Detachment of Device or Device Component; Defective Component; Detachment of Device or Device Component
IT WAS REPORTED BY CUSTOMER THAT THE ARTERIAL STAT LOCK TUBING DISCONNECTED FROM THE CONNECTION FROM THE LUER LOCK TO THE TUBING. TUBING AVAILABLE. EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17480725 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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