Statlock Arterial ART0421Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741081378), received between Jul 17, 2023 and Dec 1, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT "A BREAKAGE OF ARTERIAL LINE." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248253 ↗
• 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 17798666 ↗
• 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 17798665 ↗
• 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 17798664 ↗
• MalfunctionSep 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE ARTERIAL STATLOCK EXTENSION TUBING SPONTANEOUSLY BREAKING. ADDITIONAL INFORMATION ON 9/15: WE HAVE REVIEWED AND, IN EVERY CASE, IT IS THE SAME REPORTED COMPLAINT ¿ THE EXTENSION TUBING SPONTANEOUSLY BREAKS/TEARS AT THE PATIENT END OF THE TUBING. 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 17798663 ↗
• MalfunctionAug 9, 2023Defective Component; Defective Component

  IT WAS REPORTED VIA MEDWATCH THAT THE PATIENT BECAME AGITATED AND WAS PULLING ON HIS SOFT WRIST RESTRAINTS AND IN THE COURSE OF THAT HIS ARTERIAL LINE TUBING HAD SNAPPED AND BROKEN OFF AT HUB CONNECTED TO THE CATHETER. THE ARTERIAL LINE WAS THEN REMOVED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17491190 ↗
• MalfunctionAug 8, 2023Defective Component; Defective Component

  IT WAS REPORTED VIA MEDWATCH THAT RN NOTED ARTERIAL LINE ALARM "DISCONNECT" AND WENT INTO THE PATIENT'S ROOM TO ASSESS THE SITUATION AND OBSERVED BLOOD AT SITE OF THE ARTERIAL LINE. THE RN PERFORMED VISUAL INSPECTION AND IDENTIFIED THAT THE ARTERIAL LINE HAD BROKEN OFF AT THE HUB INTO CATHETER INSERTION. THE REMAINING CATHETER WAS REMOVED FROM THE ARTERY AND PRESSURE HELD TO STOP THE BLEEDING. NO OTHER INFORMATION PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17482900 ↗
• MalfunctionAug 2, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED BY THE CUSTOMER THAT THERE IS UNEXPECTED BREAK IN THE TUBING. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFO RECEIVED ON 20-JUL-2023. PATIENT HAD A MAINTAINED ARTERIAL AFTER CARDIAC SURGERY/HEART TRANSPLANT. IMMEDIATE POST-OP CARE AFTER CARDIAC SURGERY. ARTERIAL LINE DISCONTINUED BEFORE INDICATED, REQUIRED NEW PLACEMENT. DELAY IN ABG RESULTS, LAB DRAWS, ARTERIAL PRESSURE READING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442839 ↗
• MalfunctionAug 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER VIA MEDWATCH THAT THE ARTERIAL LINE BROKE FROM THE CONNECTION SITE RIGHT BEFORE THE STOPCOCK AND ANOTHER ARTERIAL LINE NEEDED TO BE INSERTED IN PATIENT, WHO LOST A SMALL AMOUNT OF BLOOD.

  Patient problems: Exsanguination

  MAUDE report 17439857 ↗
• MalfunctionJul 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT THE ART DISCONNECT ALARM SOUNDED, WENT IN ROOM, PT BLEEDING SIGNIFICANTLY FROM A LINE SITE, SAID SHE BARELY MOVED. PRESSURE HELD IMMEDIATELY BUT UNABLE TO GET GOOD CONTROL D/T LOCATION OF TUBE BREAKAGE. EVENTUALLY PRESSURE WAS SUCCESSFULLY HELD. ON INSPECTION TUBE WAS CRACKED IN HALF/BROKEN. PT STABLE, COMFORTABLE, ATTENDING AT BEDSIDE AWARE. THE EVENT OCCURRED ON (B)(6) 2023. RESPONSE RECEIVED (B)(6)2023 DEVICE DID NOT BREAK DURING TREATMENT. PATIENT BLEEDING SIGNIFICANTLY FROM A LINE SITE, PRESSURE HELD IMMEDIATELY BUT UNABLE TO GET GOOD CONTROL D/T LOCATION OF TUBE BREAKAGE. EVENTUALLY PRESSURE WAS SUCCESSFULLY HELD.

  Patient problems: Exsanguination

  MAUDE report 17367890 ↗
• MalfunctionJul 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT THE EXTENSION TUBING BROKE OFF FROM CATHETER HUB ON (B)(6) 2023 AROUND 8:30P. PT WAS ASLEEP IN CHAIR, NURSE SAW ON MONITOR AT NURSES STATION THAT "ART 1 LINE HAS DISCONNECTED" BEEPING ON THE MONITOR. MULTIPLE NURSES RAN INTO ROOM AND SAW THAT PATIENT WAS BLEEDING FROM ARTERIAL LINE CATHETER ONTO GOWN AND CHAIR. NURSE APPLIED PRESSURE TO SITE IMMEDIATELY WITH GAUZE AND HELD FOR 5 MINUTES. A PRESSURE DRESSING WAS APPLIED. VITAL SIGNS REMAINED STABLE THROUGHOUT INCIDENT. PATIENT DENIED ANY LIGHTHEADEDNESS OR DIZZINESS AFTERWARDS. RESPONSE RECEIVED (B)(6) 2023. DEVICE DID NOT BREAK DURING TREATMENT. PATIENT BLEED FROM ARTERIAL LINE, PRESSURE APPLIED AND BLEEDING EVENTUALLY CONTROLLED.

  Patient problems: Exsanguination

  MAUDE report 17367889 ↗
• MalfunctionJul 17, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT A-LINE DISCONNECTED AND CATHETER WAS STILL IN ARTERY, CAUSING OPEN FLOW OF BLOOD. RN WAS IN ROOM AT TIME OF DISCONNECTED AND CATHETER WAS QUICKLY REMOVED AND PRESSURE WAS APPLIED. THE EVENT DID NOT RESULT IN A DELAY IN TREATMENT. ADDITIONAL INFORMATION FROM CUSTOMER RESPONSE ON 07-05-2023: THE EVENT DID NOT INVOLVE AN URGENT OR LIFE THREATENING MEDICAL SITUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17339422 ↗