Argyle 8888160531Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 20884527005175), received between May 10, 2019 and Jul 10, 2025 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE CATHETER WAS INSERTED ON (B)(6) 2025 IN THE MORNING AT THE OBSTETRIC CENTER, AND ON (B)(6) 2025 AT NIGHT IT WAS OBSERVED THAT IT LEAKED WHEN INJECTED INTO THE PRIMARY LUMEN. THE NEWBORN WAS IN A MINIMUM HANDLING PROTOCOL, REQUIRING MANIPULATION. DURING THE INVESTIGATION, IT WAS VERIFIED THAT THERE WAS A LEAK IN THE CATHETER EXTENSION WHEN ONE OF THE ROUTES WAS USED. DUE TO THE LEAK, TWO (02) DAYS AFTER INSERTION, THE CATHETER WAS REMOVED AND A PICC WAS NECESSARY. PER CUSTOMER, THE UMBILICAL CATHETER USUALLY REMAINS IN PLACE FOR UP TO SEVEN (07) DAYS FOR PLANNING ANOTHER VENOUS ACCESS; THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475265 ↗
• MalfunctionFeb 13, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT THE LINE WAS POSSIBLY FAULTY. UPON CARE SET, THE MOTHER STATED THAT SHE FELT SOMETHING ¿WET¿ WHILE HOLDING. THE LINE WAS ASSESSED AND A ¿PINPRICK" HOLE WAS NOTED NEAR BIFURCATION OF UVC. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376135 ↗
• MalfunctionSep 20, 2024Break; Break

  THE CUSTOMER REPORTED THAT THE DOUBLE LUMEN RIGHT ATRIAL (RA) LINE WAS CRACKED. IT WAS CRACKED AFTER 4 PM ROUNDS AFTER FRESH FROZEN PLASMA (FFP) WERE GIVEN. PER CUSTOMER, WHILE INSPECTING THE DEFECTIVE RA LINE, PIECE OF TEGADERM WAS REMOVED ON BLUE LUMEN OF LINE TO INSPECT THE ¿CRACK¿, BLUE LUMEN THEN SPLIT IN 2 PIECES. THE CUSTOMER FURTHER STATED THAT SPLIT/CRACK WAS DIAGONAL AND APPEARED LIKE A CLEAN CUT POTENTIALLY. IT WAS NOT KNOWN IF THE LINE WAS ACCIDENTALLY SNIPPED WITH DRESSING CHANGE OR BROKE FROM REPEATED TENSION AT SAME SITE. THE CUSTOMER FURTHER STATED THAT THIS WAS PLACED IN THE CVOR AND THE ISSUE WAS NOTICED IN THE CCU. PER CUSTOMER, THE DEPARTMENT UTILIZE THIS DL UVC IN THE RIGHT ATRIAL POSITION WHICH THEY CALL ¿RA LINE". IN ADDITION, THE LINE WAS NOT REPLACED AFTER IT WAS PULLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267962 ↗
• MalfunctionDec 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE DOUBLE LUMEN UVC WAS INSERTED PER PROTOCOL. WHILE SECURING DEVICE WITH TAPES (PER PROTOCOL), THE INSERTER NOTED CLEAR FLUID POOLING/LEAKING AROUND THE UMBILICUS. THE FLUID CONTINUED TO RE-ACCUMULATE DESPITE DABBING WITH STERILE GAUZE. THE LINE WAS REMOVED AND REPLACED WITH A NEW LINE. UPON VISUAL INSPECTION, THERE WAS A VERY SMALL LONGITUDINAL DEFECT/HOLE NOTED AROUND THE 4-5 CM MARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18275863 ↗
• MalfunctionFeb 17, 2023Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT THE DUAL LUMEN 3.5 FR UVS HAD A HOLE IN BELOW THE JUNCTION OF THE BIFURCATION AND WAS LEAKING ON TO THE BED. THE UVC WAS REMOVED AND HAD TO BE REPLACED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397241 ↗
• MalfunctionAug 17, 2022Break; Break

  THE CUSTOMER REPORTED THAT THE DOCTOR WAS REMOVING THE DOUBLE LUMEN UVC WHEN A PORTION OF THE CATHETER OUTSIDE OF THE PATIENT SNAPPED IN HALF WITHOUT ANY DISTURBANCE TO THE CATHETER. THEY HAD TO GET AN X-RAY TO FOLLOW UP THAT THERE WASN'T A REMAINING PIECE OF THE LINE IN THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED ON AUGUST 17, 2022, THE UVC WAS INSERTED ON (B)(6) 2022. THE AREA WAS CLEANED WITH CHLORAPREP AND WAS COMPLETELY DRY PRIOR TO INSERTION. THERE WAS NO DIFFICULTY HANDLING THE CATHETER DURING INSERTION. THE UVC WAS SECURED WITH SUTURES AND THERE WAS NO DIFFICULTY SECURING IT. THE UVC WAS USED FOR CONTINUOUS FEED. THE CATHETER BODY BROKE AT ~5CM AND MEASURED 4CM AFTER THEY REMOVED THE BROKEN PART. THEREFORE, THE X-RAY WAS OBTAINED WHICH CONFIRMED NO PIECES WERE RETAINED. IT WAS REMOVED ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15240228 ↗
• MalfunctionJun 18, 2022Material Perforation; Material Perforation

  THE CUSTOMER REPORTED THAT THE CATHETER HAS A MICRO HOLE NEAR THE BASE. THE DEFECT WAS FOUND DURING TESTING BEFORE STARTING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739943 ↗
• InjuryMay 17, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE UMBILICAL CATHETER IS A STRUGGLE TO INSERT. THEY ARE SOFT, KINK EASILY, AND FLIMSY. THE TWO-LUMEN COLOR VISIBILITY IS AN ISSUE TO SEE WHEN THE BABY IS IN MECO WITH THE LIGHT ON. THERE IS NO CLAMP TO CLAMP THE LUMEN WHEN NEEDED. AFTER INSERTION, THE DOCTOR WAS UNABLE TO WITHDRAW BLOOD BACK. THE WORST PART IS AFTER THE LINE WAS REMOVED, IT BROKE. ABOUT 6CM OF THE LINE REMAINED IN THE UMBILICAL AREA. THIS WAS DETECTED AFTER X-RAY. AFTERWARDS THEY WERE ABLE TO REMOVE THE BROKEN CATHETER WITH NO HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14415024 ↗
• InjuryMay 12, 2022Break; Break

  THE CUSTOMER REPORTED THAT AT THE BEGINNING OF PLANNED REMOVAL OF THE UAC (UMBILICAL ARTERY CATHETER), THE RESIDENT TRIED TO VISUALIZE THE UA (UMBILICAL ARTERY). THEY DID NOT USE SCISSORS BUT DID MANIPULATE THE LINE WITH TWEEZERS. BLOOD BEGAN OOZING FROM THE SITE, GAUZE AND PRESSURE WAS HELD TO TRY TO CONTROL THE BLEEDING. THE PATIENT WAS BLEEDING THROUGH MULTIPLE PIECES OF GAUZE AND THE FELLOW WAS CALLED TO BEDSIDE. SURGICELL WAS BROUGHT TO THE BEDSIDE AND APPLIED TO THE SITE AND THE BLEEDING EVENTUALLY STOPPED. THE PATIENT HAD 15ML OF BLOOD LOSS. LATER A RBC (RED BLOOD COUNT) WAS ORDERED TO REPLACE BLOOD LOSS. THE PATIENT WAS NOTED TO BE OOZING BLOOD AT THE UVC SITE WITHIN 15 MINUTES OF BLOOD PRODUCT RUNNING. THE ENTIRE PEDIATRIC TEAM WAS AT THEIR BEDSIDE AND THE NP (NURSE PRACTITIONER) NOTICED A CRACK IN UVC (UMBILICAL VENOUS CATHETER). THE UVC WAS PULLED AND TWO PIVS (PERIPHERAL INTRAVENOUS LINE) WERE PLACED FOR ACCESS AND EMERGENT PICC (PERIPHERALLY INSERTED CENTRAL CATHETER). THE EVENT REQUIRED ADDITION PATIENT MONITORING. PER ADDITIONAL INFORMATION RECEIVED ON 29APR2022, THE ISSUE WITH THE CATHETER OCCURRED SOMEWHERE ON THE CATHETERS BODY. THE AREA WAS CLEANED WITH BETADINE,

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14378601 ↗
• MalfunctionMar 30, 2022Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  THE CUSTOMER REPORTED THAT THE LINES HAD AIR WHEN ASPIRATING BOTH IN VEINS AND ARTERIES WITH SOLUTION COMING OUT OF ONE SIDE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13955333 ↗
• MalfunctionFeb 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: THE INFANT HAD A DUAL LUMEN UVC PLACED ON ADMISSION. DURING NIGHT SHIFT OF 1/30 IT WAS NOTED TO BE LEAKING AT THE JUNCTION OF THE CATHETER AND THE HARD PLASTIC HUB. THE LINE WAS REMOVED AND SAVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13563320 ↗
• MalfunctionDec 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE CATHETER IS SHARP AND HARD, IT TWISTS AND CUTS EASILY CAUSING LEAKS, THE INSERTION AND SECURING OF THE LINE IS DIFFICULT, AND IT CAN ONLY STAY IN SITU FOR 5DAYS. PER ADDITIONAL INFORMATION RECEIVED, THE AREA WAS CLEANED WITH CHLORHEXIDINE AND DRIED PRIOR TO INSERTION. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE AS THE DOCTOR INVOLVED DECLINED TO ANSWER ANY FURTHER QUESTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13046837 ↗
• MalfunctionNov 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THERE WAS A LEAKING UVC LINE. PER ADDITIONAL INFORMATION RECEIVED, LEAKING WAS NOTED UPON INSERTION OF THE UMBILICAL VENOUS CATHETER. THE LINE HAD JUST BEEN SECURED AND AMINO ACIDS/DEXTROSE SOLUTION HAD COMMENCED INFUSING WHEN THE INSERTER NOTED A YELLOW TINGED FLUID LEAKING FROM THE UMBILICUS. THEY ADDED ANOTHER PURSE STRING SUTURE AS THE UMBILICAL VEIN WAS RELATIVELY LARGE BUT THE LEAKING CONTINUED. THEY ARE CONFIDENT THAT NO SUTURE NEEDLE SNAGGED/CUT THE LINE AT ANY POINT IN TIME. THE LEAK WAS OBSERVED AT THE 4 CM MARK ON THE CATHETER BODY. IT OCCURS ONLY WHEN FLUSHING THE SECONDARY (BLUE) LUMEN. THE STANDARD PRACTICE IS TO CLEAN THE UMBILICAL CORD WITH EITHER 2% CHG WITH 70% ALCOHOL OR 0.5% CHG WITH 70% ALCOHOL AND FOR THE AREA TO BE COMPLETELY DRY BEFORE INSERTION. THE DEVICE SHOULD BE SECURED WITH 2.0 SILK SUTURES AND H-TAPE TO TAPE THE LINE TO THE PATIENT. AFTER REMOVAL. THE DEVICE WAS REPLACED WITH ANOTHER DOUBLE LUMEN UMBILICAL VENOUS CATHETER INTO THE UMBILICAL VEIN. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868823 ↗
• MalfunctionNov 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: THE UMBILICAL VENOUS CATHETER (UVC) WAS FOUND TO BE LEAKING. THE LINE REMOVED AND REPLACED WITH A PICC. THE REPORTER DID NOT DOCUMENT WHERE THE LEAK WAS NOTED OTHER THAN THE SECUREMENT TAPES WERE WET AND DECISION WAS MADE TO REPLACE THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751715 ↗
• MalfunctionSep 14, 2021Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT NORMALLY THE CLEAR LUMEN IS LABELLED PRIMARY AND THE BLUE LUMEN IN LABELLED SECONDARY. THEY DISCOVERED THE CLEAR LUMEN WAS LABELLED SECONDARY AND THE BLUE LUMEN WAS LABELLED PRIMARY. PER ADDITIONAL INFORMATION RECEIVED, THE UMBILICAL VENOUS CATHETER (UVC) WAS PLACED IN A BABY AND THE LINE BECAME OBSTRUCTED; THEREFORE, THE UVC NEEDED TO BE REMOVED AND THEY NEEDED CENTRAL LINE ACCESS. THERE WAS NO ADVERSE EVENTS OR INJURIES TO PATIENT. BOTH LUMENS WERE NOTED TO BE OCCLUDED. BOTH LUMENS WERE BEING USED FOR INFUSION. THE UVC WAS INFUSING TOTAL PARENTERAL NUTRITION (TPN) AND ANTIBIOTICS AMPICILLIN AND GENTAMICIN. THERE WAS A DELAY IN BEING ABLE TO DELIVER NUTRITION TO THE BABY ONCE THE UVC WAS OCCLUDED AS IT NEEDED TO BE REMOVED AND INTRAVENOUS LINE (IV) ACCESS WAS AN ISSUE. PERIPHERAL INTRAVENOUS LINE (PIV) ACCESS WAS USED AS A REPLACEMENT. THERE WERE NO OTHER MEDICAL INTERVENTIONS. THE PATIENT IS CURRENTLY STABLE AND STILL ON RESPIRATORY SUPPORT AND FULL FEEDS. THE SAMPLE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468760 ↗
• MalfunctionSep 8, 2021Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED THERE WAS A HOLE IN THE TUBING OF THE CENTRAL LINE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12438451 ↗
• MalfunctionJul 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE DEVICE WAS LEAKING BETWEEN 11-12 CM. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE DEVICE WAS USED ON THE PATIENT FROM (B)(6) 2021 AT 02:27 TO (B)(6) 2021 AT 05:00. THE LEAKING ISSUE WAS NOTICED ON (B)(6) 2021 AT 04:00.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166793 ↗
• InjuryApr 19, 2021Break

  WHILE SUTURING A UMBILICAL CATHETER ARGYLE" VESSEL 3.5 FR. 15 INCH DUAL LUMEN, IT INADVERTENTLY BROKE AT 8 CM AND WAS UNABLE TO BE RETRIEVED. A CHEST X-RAY WAS IMMEDIATELY TAKEN AND THE LINE FRAGMENT WAS IN THE INFERIOR VENA CAVA. THE NEWBORN PATIENT WAS TRANSFERRED VIA LIFEFLIGHT TO A CHILDREN'S SPECIALTY HOSPITAL. THE NEWBORN PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY WHERE THEY WERE ABLE TO RETRIEVE THE FRAGMENT FROM THE LEFT PULMONARY ARTERY.

  Patient problems: Insufficient Information

  MAUDE report 11684776 ↗
• InjuryApr 13, 2021Break; Break

  THE CUSTOMER REPORTED WHILE SUTURING A 3.5 FR UVC CATHETER, IT INADVERTENTLY BROKE AT THE 8CM MARK AND WAS UNABLE TO BE RETRIEVED. AN X-RAY WAS IMMEDIATELY TAKEN AND THE LINE FRAGMENT WAS IN THE INFERIOR VENA CAVA. THE PATIENT WAS TRANSFERRED VIA LIFEFLIGHT TO A CHILDREN'S SPECIALTY HOSPITAL. THE BABY WAS TAKEN TO INTERVENTIONAL RADIOLOGY WHERE THEY WERE ABLE TO RETRIEVE THE FRAGMENT FROM THE LEFT PULMONARY ARTERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11657025 ↗
• MalfunctionMar 4, 2020Complete Blockage; Complete Blockage

  THE CUSTOMER REPORTED THAT THE HEPARIN WOULD NOT FLUSH THROUGH THE LINE WHEN PREPPING THE PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9787680 ↗
• MalfunctionMar 2, 2020Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED THAT WHEN ADMINISTERING THE HEPARIN THROUGH THE LINE, IT WOULD NOT FLUSH WHEN PREPPING THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9775881 ↗
• MalfunctionNov 7, 2019Break; Break

  THE CUSTOMER REPORTED THAT THE CATHETER BROKE AT THE 9 CM MARK. THE CATHETER WAS REMOVED AND A PERIPHERAL LINE WAS PLACED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9290868 ↗
• MalfunctionMay 10, 2019Complete Blockage; Complete Blockage

  THE CUSTOMER REPORTED THE SECOND PORT OF THE 3.5 DOUBLE LUMEN UMBILICAL VESSEL CATHETER CLOTTED OFF BEFORE FLUIDS COULD BE HUNG. THE CATHETER WAS INSERTED BY A PHYSICIAN AND WITHIN APPROXIMATELY 30 MINUTES AFTER COMPLETION OF INSERTION THE FLUIDS WERE HUNG AND THE LINE WAS CLOTTED. THE CATHETER WAS FLUSHED WITH HEPARIN 1:1 BY PHYSICIAN UPON INSERTION. THE CATHETER WAS REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8601343 ↗