Argyle 43304 (UDI 10884527004652)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10884527004652), received between Nov 20, 2017 and Apr 7, 2026 — classified as 2 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (25 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Crack

  THE CUSTOMER REPORTED THAT DURING STERILE DRESSING CHANGE THE LINE WAS OBSERVED TO BE CRACKED AT CONNECTION OF CATHETER AND HUB. THERE WAS NO HARM REPORTED. PER CUSTOMER, THE PATIENT REQUIRED INSERTION OF ANOTHER BRAND OF PICC LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24808843 ↗
• MalfunctionMar 2, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THERE WAS AN ORDER TO PULL THE PICC LINE OUT 1CM. AFTER PREPPING EVERYTHING AS USUAL, THEY REMOVED THE DRESSING WITH NO DIFFICULTY AND PROCEEDED TO PULL BACK THE PICC. AFTER PULLING BACK ON THE LINE JUST PAST THE INSERTION SITE, LIPIDS STARTED POURING OUT OF THE CATHETER. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484984 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PRODUCT EXPERIENCED LEAKAGE, WHICH REQUIRED REMOVAL AND ESCALATED INTERVENTION TO PLACE A PICC LINE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THAT THE DEVICE WAS PLACED ON (B)(6) 2026. ON (B)(6)2026, THE PICC WAS FOUND TO BE LEAKING AT THE HUB AND DC. ACCORDING TO THE CUSTOMER, ON (B)(6) 2026, A 1.9 SINGLE LUMEN PICC WAS PLACED. ACCORDING TO THE CUSTOMER, THE PATIENT NEEDED ADDITIONAL CENTRAL ACCESS AND POSSIBLE EXPOSURE TO INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24329437 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PRODUCT EXPERIENCED LEAKAGE, WHICH REQUIRED REMOVAL AND ESCALATED INTERVENTION TO PLACE A PICC LINE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THAT THE DEVICE WAS PLACED ON (B)(6) 2026. ON (B)(6) 2026, THE PICC WAS FOUND TO BE LEAKING AT THE HUB AND WAS DISCONTINUED. ACCORDING TO THE CUSTOMER, AFTER MULTIPLE UNSUCCESSFUL PICC ATTEMPTS BY NURSING AND PROVIDERS, ON (B)(6) 2026, THE PATIENT WAS TAKEN TO THE OR AND BROVIAC CENTRAL LINE WAS PLACED IN THE INTERNAL JUGULAR VESSEL. THE MULTIPLE ATTEMPTS CAUSE PERMANENT SCARRING OF THE VESSEL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24329423 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PRODUCT EXPERIENCED LEAKAGE, WHICH REQUIRED REMOVAL AND ESCALATED INTERVENTION TO PLACE A PICC LINE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THAT THE DEVICE WAS PLACED ON (B)(6) 2026. ON (B)(6) 2026, THE PICC WAS FOUND TO BE LEAKING AT THE HUB (THE PURPLE WING THAT CONNECTS TO THE WHITE PART OF THE PICC). AS A RESULT, THE INFANT HAD A MIDLINE PLACED THE FOLLOWING DAY. ACCORDING TO THE CUSTOMER, THE PATIENT EXPERIENCED ADDITIONAL PAINFUL IV STICKS AND AN INCREASED RISK OF INFECTION DUE TO THE UNNECESSARY ATTEMPTS.

  Patient problems: Pain

  MAUDE report 24329385 ↗
• MalfunctionDec 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE CATHETER STARTED TO LEAK AFTER 12 HOURS, AT APPROXIMATELY 2 CENTIMETERS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774161 ↗
• MalfunctionDec 10, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE CATHETER BROKE AT THE CONNECTION POINT WITH THE SET AND THE PATIENT NEEDED TO BE SEDATED FOR A NEW PUNCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23773995 ↗
• MalfunctionDec 10, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE CATHETER BROKE AT THE CONNECTOR WITH THE SET. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23773904 ↗
• MalfunctionAug 21, 2025Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT THE CATHETERS BROKE. ADDITIONAL INFORMATION RECEIVED ON 01AUG2025 STATED THAT THE LINE WAS PLACED ON (B)(6) 2025 AND BROKE ON THE (B)(6) 2025; IT HAD A HOLE IN THE PRIMARY LUMEN AT THE TRANSITION POINT WHERE THE CATHETER GETS SMALLER BELOW THE FEMALE END. THIS OCCURRED DURING PATIENT USE/LINE INFUSING. THE LINE WAS REMOVED AND REPLACED WITH A SINGLE LUMEN PICC. LABS MONITORED CLOSELY. NO HYPOGLYCEMIA OR ELECTROLYTE IMBALANCE DURING THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864919 ↗
• MalfunctionAug 7, 2025Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT THE CATHETERS BROKE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025 STATED THAT THE LINE WAS PLACED ON (B)(6) 2025 AND BROKE ON THE SAME DAY; IT HAD A HOLE IN THE PRIMARY LUMEN. THIS OCCURRED DURING PATIENT USE/LINE INFUSING. THE LINE WAS REMOVED AND REPLACED WITH A SINGLE LUMEN PICC. LABS MONITORED CLOSELY. NO HYPOGLYCEMIA OR ELECTROLYTE IMBALANCE DURING THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745390 ↗
• MalfunctionMar 20, 2024Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THEY ARE UNABLE TO FLUSH CATHETER PRIOR TO INSERTING INTO NEONATE. IT WAS NOT USED. THE SECONDARY PORT WAS BLOCKED. THERE WAS NO HARM REPORTED AS IT WAS DETECTED BEFORE USE AND DID NOT REACH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944633 ↗
• MalfunctionMar 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT AFTER THE PICC DRESSING WAS MOIST, THE PRIMARY ROUTE WAS OBSERVED WITH MEDICATION EXITING THROUGH THE INSERTION, AND THE SECONDARY ROUTE WAS OBSERVED WITH GOOD INFUSION. THE CATHETER WAS PULLED AND A HOLE IN THE PRIMARY ROUTE WAS FOUND. THERE WAS A NEED TO REMOVE THE CATHETER. THE CATHETER WAS NOT EXTERNALIZED. THERE WAS NO HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE CATHETER WAS NOT OUT. THE CATHETER WAS LEAKING INSIDE THE PATIENT`S VEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944480 ↗
• MalfunctionJun 12, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  CUSTOMER REPORTS: THE PICC IS 30 CM LONG, BUT FROM 27 CM IT HAS NO MARKINGS. WE NEEDED TO PASS TO THE LOWER LIMB AND THE MEASUREMENT WAS 28CM, HOWEVER CUTTING WITHOUT MARKING THE SIZE IS NOT RELIABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17113581 ↗
• MalfunctionMay 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING DAILY LINE CHECKS, PICC LINE PATCH WAS NOTED TO BE SATURATED WITH FLUID POOLING AROUND PATCH AND WAS LEAKING OUTSIDE OF DRESSING. CHARGE REGISTERED NURSE (RN) AND BEDSIDE RN REMOVED THE DRESSING. THE BEDSIDE RN FLUSHED THE LINE WITH DRESSING OFF. THE FLUID WAS NOTED TO BE LEAKING OUT OF INSERTION SITE. PER NEONATAL NURSE PRACTITIONER (NNP) ORDER, RN PULLED THE LINE, AND THE TOTAL LINE MEASUREMENT MATCHED THE INSERTION NOTE. AFTER THE LINE WAS PULLED, NO CRACK OR HOLE WAS FOUND IN THE LINE AFTER FLUSHING. THE FLUID CAME DIRECTLY OUT OF THE TIP OF THE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE CATHETER WAS INSERTED ON (B)(6) 2023 IN LEFT FEMORAL, CHLORHEXIDINE GLUCONATE (CHG) WAS USED TO CLEAN THE SKIN AREA PRIOR TO INSERTION. THE AREA WAS COMPLETELY DRIED PRIOR TO INSERTION. THERE WAS NO DIFFICULTY IN HANDLING AND SECURING THE CATHETER DURING INSERTION. IT WAS UNKNOWN THAT WHAT WAS USED TO SECURE THE CATHETER AT THE TIME OF INSERTION AND AT THE TIME OF REMOVAL, SECUREPORT IV WAS BEING USED. PER CUSTOMER, THE CATHETER WAS USED CONTINUOUSLY, AND THE CUSTOMER HAS USED CHG CLEANER WHEN PERFORMING DRESSING CHANGES AND ALCOHOL WIPES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16870341 ↗
• MalfunctionApr 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS THAT THEY WERE CALLED TO THE BEDSIDE TO ASSESS WITH A PICC AS DRESSING WAS SATURATED. UPON ASSESSMENT, AND FLUSHING OF BOTH PORTS, FLUIDS NOTED TO BE LEAKING AT INSERTION SITE. THE DOCTOR AT BEDSIDE SUGGESTED PULLING THE PICC BACK 5CM AND USING IT AS PERIPHERAL, HOWEVER THE PICC CONTINUED TO LEAK. THE PICC WAS THEREFORE REMOVED, AND THE LINE WAS INTACT. THE PATIENT TOLERATED IT WELL. PLACEMENT OF A SECOND PICC WILL BE ATTEMPTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16745764 ↗
• MalfunctionMar 27, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED MOISTURE WAS NOTED UNDER THE PICC DRESSING, THE CHARGE NURSE NOTIFIED OF POSSIBLE PICC LEAKING AT OR NEAR THE INSERTION SITE. FELLOW TO BEDSIDE. PICC CATHETER WAS FOUND TO BE LEAKING WHERE IT JOINS THE SECUREMENT BUTTERFLY DEVICE THAT IS PART OF THE LINE. THE PICC WAS REMOVED AND 7 VENIPUNCTURE ATTEMPTS WERE MADE TO ESTABLISH VENOUS ACCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16619019 ↗
• MalfunctionMar 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE PICC LEAKED INTO MI, SINCE IT WAS IN THE CENTRAL POSITION. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16540501 ↗
• MalfunctionMar 7, 2023Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED DURING THE PREPARATION OF THE MATERIAL FOR THE PROCEDURE, WHEN WASHING THE PRIMARY LUMEN WITH 0.9% PHYSIOLOGICAL SOPHUS, AN OBSTRUCTION OF THE CATHETER WAS OBSERVED, MAKING IT IMPOSSIBLE TO USE IT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16494853 ↗
• MalfunctionFeb 13, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  CUSTOMER REPORTS: DURING USE THE 1.9 FRENCH DOUBLE LUMEN PICC LINE NOTED TO BE CRACKED RIGHT NEXT TO THE PURPLE PLASTIC STABILIZER. THERE WAS NO HARM TO THE PATIENT. A NEW LINE WAS REQUIRED. THERE WAS NO HARM TO THE PATIENT. A NEW LINE WAS REQUIRED. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON 2/10/22 CLARIFIED THAT A LEAK OCCURRED JUST ABOVE THE BUTTERFLY WHERE THE EXTENSION TUBING MEETS THE BUTTERFLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16367916 ↗
• MalfunctionFeb 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PICC LINE NOTED TO BE LEAKING THROUGH THE CATHETER. THE LINE WAS SAVED BY BEDSIDE STAFF. THERE WAS NO PATIENT HARM. THE PATIENT FELT INCONVENIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277567 ↗
• MalfunctionSep 23, 2022Difficult to Flush; Difficult to Flush

  CUSTOMER REPORTS: THE CATHETER OBSTRUCTS VERY EASILY WITHIN A SHORT TIME OF USE, EVEN WITH SUITABLE CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15469736 ↗
• MalfunctionApr 28, 2022Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT A CATHETER OBSTRUCTION WAS VERIFIED AT THE TIME OF FILLING THE LUMEN WITH SALINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14238937 ↗
• MalfunctionApr 15, 2022Break; Break

  THE CUSTOMER REPORTED THAT THE CATHETER WAS REVIEWED BECAUSE THE HEALING WAS OBSERVED TO BE WET, IT WAS WITHDRAWN 12 CM AND AFTER 10 CM IT PRESENTED A BREAK (2 CM INTRODUCED INTO THE PATIENT). THE CCP HAD TO BE CHANGED, WHICH IMPLIES IN A NEONATAL PATIENT. PER ADDITIONAL INFORMATION RECEIVED ON 13APR2022, THE BREAK OCCURRED SOMEWHERE IN THE CATHETER¿S BODY. AT 10 CM FROM INSERTING THE PICC, IT PRESENTED A PERFORATION, WHICH THEY REALIZED WHEN CURING THE PATIENT. THE AREA WAS CLEANED WITH CHLORHEXIDINE WITHOUT AN ALCOHOL BASE (AND IN PREMATURE BABIES THEY USE 70% ALCOHOL) AND DRIED PRIOR TO INSERTION. IT WAS NOT DIFFICULT TO HANDLE OR SECURE THE CATHETER. THE CATHETER WAS SECURED WITH GAUZE WITH FIXOMULL. THEY USED A DOUBLE LUMEN WITH CONTINUOUS IRRIGATION. THEY USED A SYRINGE OF 1 AND 3 CC TO FLUSH THE LINES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14120787 ↗
• MalfunctionOct 21, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT A 1.9 FR PICC LINE WAS MALFUNCTIONED. THE LINE WAS INSERTED ON (B)(6) 2021 AND FLUSHED WITH EASE. LATE DURING AN EMERGENT EVENT THE LINE WAS NOTED TO HAVE A RUPTURE WITH LEAK OF FLUID ALONG THE CLEAR SILICONE DISTAL TO THE BLUE CLAVE AND PROXIMAL TO THE ¿BUBBLE¿. THE LINE WAS IMMEDIATELY REMOVED, INTACT. PER CUSTOMER, DUE TO THE EVENT THERE WAS A DELAY IN CARE FOR PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 12673428 ↗
• MalfunctionOct 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT, A PATIENT¿S ARGYLE DOUBLE LUMEN PICC LINE WAS FOUND TO BE CRACKED AND LEAKING. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE CATHETER WAS INSERTED ON (B)(6) 2021 IN LEFT BRACHIAL. PRIOR TO INSERTION THE SKIN AREA WAS CLEANED. THE AREA WAS COMPLETELY DRIED PRIOR TO INSERTION. THE PREVANTICS WAS USED TO CLEAN THE DEVICE. THE PREVANTICS WAS NOT USED TO CLEAN THE CATHETER TUBING. THERE WAS NO DIFFICULTY IN HANDLING THE CATHETER DURING INSERTION. THE CATHETER WAS SECURED WITH STAT SEAL, TRANSPARENT DRESSING, STERI STRIPS. PER CUSTOMER, THE CATHETER WAS USED CONTINUOUSLY FOR IV FLUIDS AND 10 ML SYRINGE WAS USED TO FLUSH THE MED LINE REGULARLY. ON (B)(6) 2021, THE PATIENT¿S ARGYLE DOUBLE LUMEN PICC LINE WAS FOUND TO BE CRACKED AND LEAKING AT JUST BELOW THE MOLDED STRAIN RELIEF ON THE PRIMARY EXTENSION TUBING (CLEAR). THE LINE WAS DISCONTINUED, AND 24 G PIV WAS USED AND ON (B)(6) 2021, REPLACED WITH SINGLE LUMEN PICC. THERE WAS NO PATIENT HARM REPORTED. THE CUSTOMER FURTHER PROVIDED MORE INFORMATION AND STATED THAT THEY USED PREVANTICS TO CLEAN THE HUB ITSELF, NOT THE LINE, ON MONDAYS AND THURSDAYS WHEN THEY CHANGE OUT THE NEEDLESS CAP. THE REST OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579789 ↗