Argyle 43309Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884527004676), received between May 17, 2019 and Aug 7, 2025 — classified as 11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  THE CUSTOMER REPORTED THAT WHEN STAFF ATTACHED THE NEW TUBING, IT WOULD CONSTANTLY ROTATE BUT WOULD NOT SECURE. THEY THEN TRIED A DIFFERENT ANTI-REFLUX AND THE SAME THING HAPPENED. PICC WAS INSERTED UNDER STERILE CONDITIONS AND PLACEMENT CONFIRMED WITH X-RAY. WHEN HOOKING UP TO IV FLUIDS, NOTED THAT THE HUB OF THE CATHETER WAS DEFECTIVE/BROKEN AND ANTI-REFLUX VALVE, FLUSH, ETC WOULD NOT SCREW ON TIGHTLY AND LOCK IN PLACE. WITH NO WAY TO ENSURE THAT THE LINE WOULD NOT BE DISRUPTED/EXPOSED, PICC NEEDED TO BE REPLACED. THE CUSTOMER PROVIDED THE LOT INFORMATION FOR THE PICC WITHIN THE INSERTION KIT AS WELL: PRODUCT 43303, LOT 2221100054, EXP 2027-06-30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742764 ↗
• MalfunctionAug 7, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  THE CUSTOMER REPORTED THAT WHEN STAFF ATTACHED THE NEW TUBING, IT WOULD CONSTANTLY ROTATE BUT WOULD NOT SECURE. THEY THEN TRIED A DIFFERENT ANTI-REFLUX AND THE SAME THING HAPPENED. PICC WAS INSERTED UNDER STERILE CONDITIONS AND PLACEMENT CONFIRMED WITH X-RAY. WHEN HOOKING UP TO IV FLUIDS, NOTED THAT THE HUB OF THE CATHETER WAS DEFECTIVE/BROKEN AND ANTI-REFLUX VALVE, FLUSH, ETC WOULD NOT SCREW ON TIGHTLY AND LOCK IN PLACE. WITH NO WAY TO ENSURE THAT THE LINE WOULD NOT BE DISRUPTED/EXPOSED, PICC NEEDED TO BE REPLACED. THE CUSTOMER PROVIDED THE LOT INFORMATION FOR THE PICC WITHIN THE INSERTION KIT AS WELL: PRODUCT 43303, LOT 2221100054, EXP 2027-06-30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742762 ↗
• MalfunctionMar 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PICC CATHETER WAS LEAKING FROM THE LINE. THE INDWELLING TIME OF THE CATHETER WAS 7 DAYS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11411637 ↗
• MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT LEAKING FROM PICC AFTER INSERTION WAS OBSERVED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11403982 ↗
• MalfunctionMar 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PICC CATHETER WAS LEAKING FROM THE LINE. THE CUSTOMER NOTICED A PIN HOLE AT THE JUNCTION. THE INDWELLING TIME OF THE CATHETER WAS 6 DAYS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11403923 ↗
• MalfunctionMay 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PICC LINE WAS IN FROM (B)(6) 2020 - (B)(6) 2020. THERE WAS A HUB CHANGE THE NIGHT BEFORE AT 10:00 PM (MONDAY, (B)(6)). DURING THE DRESSING CHANGE, THEY NOTICED A LOOSE STERI-STRIP. ON TUESDAY AT 1:00 PM, THE PICC TEAM NOTICED THAT THERE WAS A LEAK ON THE PICC. THE PATIENT HAD TO GET A MID-LINE. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT STATED THAT THE ISSUE OCCURRED JUST ABOVE THE BUTTERFLY WHERE THE EXTENSION TUBING MEETS THE BUTTERFLY. THE HUB WAS CHANGED ON (B)(6) 2020. LEAKING WAS DISCOVERED ON (B)(6) 2020. THEY NOTED THAT DURING THE DRESSING CHANGE THE ORIENTEE USED A CHG WIPE TO HOLD THE LINE INSTEAD OF A 4X4 GAUZE. CHLORAPEP WAS USED TO CLEAN THE AREA. THE AREA WAS COMPLETELY DRIED PRIOR TO INSERTION. THERE WAS NO DIFFICULTY IN HANDLING THE CATHETER DURING INSERTION AND IT WENT RIGHT IN. IT WAS DIFFICULT TO SECURE THE INSERTION SITE BECAUSE THE PATIENT WAS SWEATY. THE CLAMP THAT COMES WITH THE CATHETER WAS USED. THE DEVICE WAS INSERTED ON THE RIGHT BASILIC VEIN IN THE ARM. IT WAS CONTINUOUS USE BUT WITH ANTIBIOTICS PERIODICALLY. 10ML SYRINGE WITH NORMAL SALINE WAS USED TO FLUSH LINES. PREVANTICS W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10051520 ↗
• MalfunctionNov 1, 2019Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  THE CUSTOMER REPORTED THE PICC LINE WAS PLACED ON (B)(6) AT 1208. THE FLOOR PAGED VAT AT 2300 FOR LEAKING. THE DRESSING WAS SATURATED. VAT REMOVED THE DRESSING AND NOTED THAT THE LINE WAS LEAKING AT THE INSERTION SITE. THE LINE WAS REMOVED AND NOTED TO HAVE A SMALL HOLE IN IT ABOUT 7CM FROM THE HUB. 3CM OF THE LINE WAS LEFT EXTERNAL, SO ABOUT 4CM WERE INSIDE OF THE PATIENT. THE CUSTOMER FURTHER STATED NO MEDICAL INTERVENTION WAS NEEDED ASIDE FROM CHANGING THE PICC WITH A PERIPHERAL IV LINE. THE LEAK WAS LOCATED ON THE CATHETER BODY. CHLORAPREP WAS USED TO CLEAN THE SKIN PRIOR TO INSERTION. THE AREA WAS COMPLETELY DRIED PRIOR TO INSERTION. THE PICC WAS REMOVED ON (B)(6) 2019. THE PATIENT IS STABLE, THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268572 ↗
• MalfunctionOct 7, 2019Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT THE PICC CONTINUED TO BLEED BACK AND A CRACK IS OBSERVED IN THE PICC LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9161332 ↗
• MalfunctionAug 9, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE CATHETER WAS LEAKING. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8878837 ↗
• MalfunctionJul 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THEY HAD TO REMOVE THE PICC LINE DUE TO LEAKING NOTED AT THE CATHETER HUB. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8836804 ↗
• MalfunctionMay 17, 2019Break; Break

  THE CUSTOMER REPORTS AFTER INSERTION, THE PICC BROKE WHILE THE DRESSING WAS BEING CHANGED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8620835 ↗