Argyle 8888160341 (UDI 20884527005120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 20884527005120), received between Apr 14, 2017 and May 13, 2025 — classified as 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (21 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE CATHETER PRESENTED MEMORY AND EXTRAVASATION. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22015531 ↗
• MalfunctionApr 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE ITEM PRESENTED MEMORY AND EXTRAVASATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876194 ↗
• MalfunctionJan 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE UMBILICAL CATHETER WAS LEAKING. THERE WAS NO DIFFICULTY IN INSERTION. PER CUSTOMER, THEY HAD TO REMOVE THE CENTRAL LINE BECAUSE QUESTIONABLY SEPTIC INFANT LOST ALL ANTIBIOTIC THAT WAS GIVEN PLUS APPROXIMATELY 20 ML OF IV FLUID.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21267654 ↗
• MalfunctionMay 8, 2024Break; Break

  THE CUSTOMER REPORTED THE RN WAS ATTEMPTING TO REMOVE THE UVC CATHETER THAT WAS PLACED AT 10CM. THE DRESSING WAS REMOVED, AND THE SUTURES WERE LOOSENED WITH USE OF THE TWEEZERS AND SCISSORS IN THE SUTURE KIT. THE RN STABILIZED THE BASE OF THE CORD WITH THE LEFT HAND AND USED THE TWEEZERS FROM THE SUTURE KIT TO BEGIN REMOVING THE CATHETER SLOWLY WITH THE RIGHT HAND. THE CATHETER CAME OUT EASILY UNTIL THE 6.5CM MARK. THE LINE THEN BROKE OFF SUDDENLY. MINIMAL TENSION HAD BEEN USED WHILE REMOVING THIS LINE. THE LINE WAS STICKING OUT OF THE UMBILICUS. THE RN QUICKLY CLAMPED THE LINE WITH THE SAME HAND USED TO STABILIZE THE BASE, AND THEN CALLED THE CHARGE RN FOR ASSISTANCE. THE BASE OF THE LINE WAS CLAMPED. THEY THEN REMOVED THE REMAINDER OF THE LINE WITH ASSIST FROM THE RESOURCE RN. THE CATHETER WAS COMPLETE FOR A TOTAL OF 10CM. HOMEOSTASIS WITHIN NORMAL TIME FRAME AND GAUZE DRESSING WAS APPLIED TO THE SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267584 ↗
• MalfunctionApr 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THEY HAD NOTICED UVC LINE WAS LEAKING AT CLAVE SITE. PER CUSTOMER, THEY VERIFIED THE CONNECTIONS AND WERE TIGHT AT START OF THE SHIFT. THE CHARGE WAS NOTIFIED, AND TRANSPORT NURSE WAS CALLED. FELLOW WAS THEN NOTIFIED AND CAME TO ASSESS THE PATIENT. A DECISION WAS MADE TO INSERT A PICC LINE AND UVC WAS REMOVED. THE CUSTOMER FURTHER STATED THAT THE CONNECTOR BEING USED WAS MC100 ICU MEDICAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19168357 ↗
• MalfunctionMar 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: THE PRODUCT IS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18938200 ↗
• MalfunctionFeb 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE LINE WAS FLUSHED WITH NS AND PLACED IN UMBILICAL VEIN. BUBBLES WERE NOTED WHEN PULLING BACK ON THE SYRINGE AND THERE WAS LEAKING AT THE CATHETER HUB. NO AIR/BUBBLES REACHED THE PATIENT. THE LINE WAS IMMEDIATELY REMOVED AND A NEW PRIMED FOOTPRINT LINE WAS PLACED WITHOUT DIFFICULTY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378583 ↗
• MalfunctionDec 16, 2022Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PATIENT WAS BEING HELD WHEN THE FAMILY NOTICED BLOOD BACKING UP INTO THE LINE AND DRIPPING OUTSIDE OF THE TUBING SUDDENLY. SHE HIT HER CALL LIGHT AND THE STAFF CAME TO THE BEDSIDE TO ASSESS. THERE WAS A CRACK IN THE UMBILICAL VENOUS CATHETER (UAC) LUMEN. THIS CRACK WAS NOT PRESENT EARLIER IN THE SHIFT AS THE STAFF HAD BEEN USING THE LINE FOR LABS. THE STAFF NOTIFIED THE ADVANCED PRACTICE NURSE (APN) WHO THEN CAME TO BEDSIDE TO REMOVE THE LINE. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT IT BEING A VERY SLOW DRIP, MIGHT BE A TOTAL OF 1-2CC OF BLOOD DRIPPED BEFORE SHE WAS ABLE TO GET TO BEDSIDE TO REMOVE THE LINE. PER CUSTOMER, THE DEVICE WAS REMOVED ON (B)(6) 2022, AND WAS NOT REPLACED. FURTHER INFORMATION WAS RECEIVED AND STATED THAT PER CUSTOMER, POVIDONE IODINE WAS USED TO CLEAN THE SKIN AREA PRIOR TO INSERTION. THE LINE WAS SECURED WITH TEGADERM AND THE ¿GOAL POST¿ SECUREMENT DEVICE. THE DEVICE WAS INSERTED ON (B)(6) 2022. THE CUSTOMER FURTHER STATED THAT THE LINES WOULD HAVE BEEN FLUSHED WITH LABS OR IF THE PATIENT RECEIVED INTERMITTENT IV MEDICATIONS. THEY ALSO RUN HEPARINIZED FLUIDS THROUGH EACH LUMEN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15996144 ↗
• MalfunctionNov 16, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE CUSTOMER REPORTED THAT THE UMBILICAL CATHETER WAS INSERTED AND THEN WAS NOTED TO NOT HAVE ANY MEASUREMENT MARKINGS ON. IT WAS ALREADY INSERTED WHEN THE TEAM REALIZED THIS. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15809155 ↗
• MalfunctionSep 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE UMBILICAL VESSEL CATHETER (UVC) HAD A HOLE IN IT AND WAS LEAKING. THEY PLACED IT IN THE PATIENT ON (B)(6) 2022 AND SAW THAT BLOOD WAS DRIPPING FROM THE TUBING, NOT A CONNECTOR. THERE WAS NO SIGNIFICANT BLOOD LOSS AND THE DEVICE WAS IN PLACE FOR LESS THAN A DAY. A NEW UVC WAS REPLACED IMMEDIATELY AFTER INITIAL INSERTION WITHOUT ANY ADDITIONAL COMPLICATIONS. HOWEVER, THE PATIENT UNDERWENT ADDITIONAL X-RAY EXPOSURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15422249 ↗
• MalfunctionMar 14, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE CATHETER HAD A CRACK IN THE LINE. NO INJURY BUT THE NEONATE DID HAVE SOME LOSS OF BLOOD. ADDITIONAL INFORMATION RECEIVED ON 14-MAR-2022 STATED THAT THE CRACK WAS NOTICED JUST BELOW THE HUB WHERE THE CATHETER IS JOINED CAUSING THE DEVICE TO LEAK. THE DEVICE WAS INSERTED ON (B)(6) 2022. THE AREA WAS CLEANED WITH BETADINE PRIOR TO INSERTION. THE DEVICE WAS NOT DIFFICULT TO HANDLE DURING INSERTION AND IT WAS NOT DIFFICULT TO SECURE, SECURED WITH A SUTURE AND THEN GOAL POST-TAPING. THE LINE WAS FLUSHED WITH 0.9 NACL AND A 5ML SYRINGE PRIOR TO INSERTION AND AT LEAST THREE MORE TIMES WITH NO FLUID LEAK NOTED. WHEN BLOOD WAS DRAWN BACK FROM THE LINE FOR LAB WORK SEVERAL HOURS AFTER INSERTION BLOOD WAS NOTED LEAKING FROM THE CRACK. ALCOHOL WAS USED TO CLEAN THE HUB PRIOR TO BLOOD DRAW. AMOUNT OF BLOOD LOSS WAS A MINIMAL AMOUNT, THE PATIENT DID NOT EXPERIENCE ANY CLINICAL SYMPTOMS DUE TO THIS ISSUE. A NEW 5F SINGLE LUMAN UAC WAS PLACED IMMEDIATELY FOLLOWING THE REMOVAL OF THE CRACKED LINE. NO ADDITIONAL INTERVENTION OR TREATMENT REQUIRED. THE PATIENT'S CURRENT STATUS IS UNKNOWN AS THE INFANT WAS TRANSFERRED FOR HIGHER LEVEL OF CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13758662 ↗
• 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. THERE IS NO SUPPORTING EVIDENCE CONFIRMING VEIN PERFORATION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13046838 ↗
• MalfunctionMay 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: THE SINGLE LUMEN UMBILICAL ARTERIAL CATHETER WAS LEAKING BLOOD. IT WAS NOTED THAT THERE WAS A HOLE IN THE CATHETER TUBING WITHIN THE FIRST 2 INCHES FROM CONNECTION END.

  Patient problems: Insufficient Information

  MAUDE report 11802627 ↗
• MalfunctionFeb 26, 2021Crack; Crack

  THE CUSTOMER REPORTED WHILE CHANGING THE UMBILICAL ARTERY CATHETER (UAC) INFUSIONS (DOWN TO CLAVE) WHILE STERILE THEY WERE HOLDING THE UAC IN THEIR LEFT HAND AND THE NEW INFUSIONS IN THE RIGHT AS USUAL. THE CARE PROVIDER HAD THE UAC PINCHED IN THEIR LEFT HAND TO PREVENT IT FROM BLEEDING BACK, AS THEY NORMALLY DO. AS THE CARE PROVIDER WENT TO CONNECT THE INFUSIONS, THE UAC CRACKED BELOW THE HUB WHERE IT WAS BEING PINCHED. THE UAC WAS CLAMPED AND REMOVED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11385008 ↗
• MalfunctionFeb 2, 2021Complete Blockage; Fluid/Blood Leak; Complete Blockage; Fluid/Blood Leak

  THE CUSTOMER REPORTED BLOOD BACKING UP IN THE UVC. THE TRANSPORT NURSE WAS AT THE BEDSIDE TO TROUBLESHOOT. THE INFUSION RATE OF D10W WITH HEPARIN WAS INCREASED TO TRY TO CLEAR LINE (TKVO PRIOR). THEN THE BED WAS OBSERVED TO BE WET AND LEAKING OF SOLUTION VISIBLE FROM UPPER PART OF UVC LINE A FEW CENTIMETERS BELOW THE CLAVE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269830 ↗
• MalfunctionJan 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS THAT THE DEVICE MALFUNCTIONED DURING USE ON A PREMATURE NEWBORN BABY. THE DEVICE WAS WORKING BUT "HAS STOPPED READING WELL" DUE TO A LEAKAGE. ON 1/8/2021 ADDITIONAL INFORMATION STATES: THE UAC STOPPED READING WELL, SO THE LINE WAS INSPECTED. BLOOD WAS NOTED TO BE BACKING UP INTO CATHETER SO ALL CLAMPS WERE CHECKED AND VERIFIED FLUID WAS INFUSING. THE UAC WAS FLUSHED AND NOTED THERE WAS A LEAK IN THE LINE WHERE IT CONNECTS TO THE HUB. THE UAC WAS CLAMPED BELOW THE LEAK, BUT PER MD HAD TO BE LEFT IN UNTIL OFF THE ECMO CIRCUIT, WHICH WASN'T CUT AWAY UNTIL THE END OF THE SHIFT. THIS RESULTED IN THE LOSS OF AN ARTERIAL LINE FOR AN ECMO TRIAL AND CUT AWAY, AND LEFT NO DRAWABLE LINES FOR GASES RESULTING IN POKES OF A HEPARINIZED INFANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11143328 ↗
• MalfunctionNov 20, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THEY ARE NOT ABLE TO DRAW BLOOD USING THE 5.0 FR UMBILICAL VENOUS CATHETER (UVC). THERE WAS NO PATIENT HARM INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10877625 ↗
• MalfunctionMay 13, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT UPON UNBUNDLING THE PATIENT AFTER PICC INSERTION (IN IR) IT WAS NOTED THAT THERE WAS A LARGE AMOUNT OF BLOOD ON THE BLANKET. THE SOURCE WAS IDENTIFIED AS A CRACK IN THE UVL CATHETER (C JUNCTION BETWEEN CATHETER AND PLASTIC LUER LOCK ADAPTER). THE CONSEQUENCE TO THE PATIENT WAS BLOOD LOSS.

  Patient problems: Blood Loss

  MAUDE report 10053642 ↗
• MalfunctionMay 4, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT FLUIDS WERE LEAKING FROM THE UVC. THE FLUID APPEARED TO BE LEAKING FROM 2 CM BELOW THE CONNECTION POINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10021201 ↗
• MalfunctionMar 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT SMALL AMOUNT OF BLOOD WAS FOUND. A SMALL HOLE WAS FOUND IN TUBING AT CONNECTION SITE. THE LINE WAS CLAMPED AND FLUSHED TO ASSESS FOR SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9862926 ↗
• InjuryFeb 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THERE WAS BLOOD LEAKING FROM THE CATHETER AND A NEW LINE HAD TO BE REPLACED SINCE THE PATIENT LOST 6-7ML OF BLOOD, THEY HAD CAUGHT IT BEFORE FURTHER BLOOD LOSS.

  Patient problems: Blood Loss; Tachycardia

  MAUDE report 9740707 ↗
• MalfunctionJan 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE CATHETER STARTED LEAKING NEAR THE HUB TWO DAYS AFTER INSERTION. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THE CATHETER WAS REMOVED AND A NEW CATHETER WAS INSERTED BY THE PROVIDER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9621909 ↗
• MalfunctionNov 8, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  THE CUSTOMER REPORTED THE UVC WAS INSERTED ON (B)(6). ACCORDING TO THE NURSE COORDINATOR, UVC FLUIDS WERE INFUSING WITHOUT ANY ISSUES UNTIL (B)(6) AT 0530 WHEN THE RN OBSERVED THAT THE INFANT¿S BED WAS WET. FLUID WAS NOTED DRIPPING FROM THE CATHETER AND NOT THE IV TUBING. THE CATHETER APPEARED TO HAVE A HOLE. THE NURSE PRACTITIONER WAS NOTIFIED BY THE RN AND THE CATHETER WAS REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9297026 ↗
• MalfunctionSep 20, 2019Break; Break

  THE CUSTOMER REPORTED THAT THE ARGYLE UMBILICAL CATHETER BROKE INTO TWO PIECES WHEN THE RN WAS REMOVING IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9100767 ↗
• MalfunctionAug 13, 2019Fluid/Blood Leak; Migration; Fluid/Blood Leak; Migration

  THE CUSTOMER STATED THAT THE CATHETER IS TOO SOFT AND BENDS ON INSERTION AND MOVES OUT OF PLACE (MIGRATES). THE CUSTOMER FURTHER STATED THAT DURING ONE INCIDENT THE CATHETER LEAKED INTO THE ABDOMEN. NO ADDITIONAL INCIDENT DETAILS WERE ABLE TO BE PROVIDED BY THE CUSTOMER.

  Patient problems: No Information

  MAUDE report 8890771 ↗