Argyle 43303Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10884527004645), received between Jul 16, 2019 and Apr 2, 2026 — classified as 1 death, 3 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Fluid/Blood Leak

  THE CUSTOMER REPORTED LEAKAGE FROM THE PICC EXTERNAL TUBING, LOCATED BELOW THE HUB AND ABOVE THE WINGS. THERE WAS NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772444 ↗
• MalfunctionOct 21, 2025Break; Break

  THE CUSTOMER REPORTED THEY FOUND THAT THE PICC LINE WAS NOT ATTACHED TO THE FLANGE/HUB. THE LINE WAS SEPARATED. PER CUSTOMER, THUMB WAS PLACED ON THE LINE TO KEEP DEVICE EXTERNAL TO THE PATIENT AND STOPPED THE INFUSIONS. THE ISSUE WAS REPORTED TO THE RESIDENT, ATTENDING, CERTIFIED REGISTERED NURSE (CRN), AND THE PHARMACY. THE CRN PULLED THE PICC AND PLACED THE DEVICE IN A STERILE CONTAINER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE PICC WAS INSERTED ON (B)(6) 2025, AND THE INCIDENT OCCURRED ON (B)(6) 2025. THERE WAS A DELAY IN TREATMENT AND A NEW PICC WAS INSERTED AS A RESULT. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352174 ↗
• MalfunctionSep 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT EXTRAVASATION WAS OBSERVED AT THE CATHETER CONNECTION WITH THE BUTTERFLY VALVE. THE CATHETER REMAINED IN THE PATIENT FOR 7 DAYS. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069362 ↗
• MalfunctionAug 23, 2024Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT NEONATAL ICU HAS REPORTED THAT THE ARGYLE PICC HAD ISSUE RELATED TO LUER LOCK BEING STRIPPED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THERE WERE NO ISSUES INITIALLY WITH CONNECTING AT THE LUER LOCK ON INSERTION, BUT OVER TIME IT BEGAN TO WEAR AWAY AND APPEARED TO BE STRIPPED. THE LINE HAS BEEN INDWELLING FOR 10 DAYS UPON DISCOVERING THE ISSUE. THE FACILITY DOES TUBE CHANGE EVERY 3 DAYS. THIS BABY HAD 3 TUBING CHANGES DONE. UPON 3RD TUBING CHANGE, THE NEEDLELESS CONNECTOR CONTINUED TO SPIN AND WOULD NOT LOCK. THERE WAS NO ISSUE WITH THE CATHETER CONNECTION WITH THE BUTTERFLY. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20057313 ↗
• MalfunctionAug 23, 2024Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT NEONATAL ICU HAS REPORTED THAT THE ARGYLE PICC HAD ISSUE RELATED TO LUER LOCK BEING STRIPPED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THERE WERE NO ISSUES INITIALLY WITH CONNECTING AT THE LUER LOCK ON INSERTION, BUT OVER TIME IT BEGAN TO WEAR AWAY AND APPEARED TO BE STRIPPED. THE LINE HAS BEEN INDWELLING FOR 14 DAYS UPON DISCOVERING THE ISSUE. THE FACILITY DOES TUBE CHANGE EVERY 3 DAYS. THIS BABY HAD 4 TUBING CHANGE DONE. UPON 4TH TUBING CHANGE, THE NURSE NOTICED LOOSE CONNECTION, BUT THE INFANT WAS NOT STABLE FOR LINE TO BE PULLED. THERE WAS NO ISSUE WITH THE CATHETER CONNECTION WITH THE BUTTERFLY. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049535 ↗
• MalfunctionAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THEY HAD A PICC LINE THAT WAS LEAKING FROM THE TUBING CLOSEST TO THE END OF THE TUBING BY THE BUTTERFLY/"THE HUB. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039979 ↗
• MalfunctionAug 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE CENTRAL PICC IN THE L AC WAS LEAKING FROM THE TUBING CLOSEST TO THE END OF THE TUBING BY THE BUTTERFLY/"THE HUB". A HOLE WAS FOUND AT THAT POINT AND THE FLUID LIKELY DID NOT REACH THE BED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THEY NEEDED TO REMOVE THE LINE THAT WAS NEEDED FOR THE PATIENT. PER CUSTOMER, WHILE THIS ISN¿T A DIRECT INJURY IT DID CAUSE THE PATIENT TO BE POKED AGAIN FOR ANOTHER LINE/IV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20019755 ↗
• MalfunctionOct 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: THE BABY WAS RETURNED TO THE MOTHER TO HOLD AND IT WAS NOTICED THAT THE SCALP PICC LINE FELT WET. THE LINE WAS DRIED AND REASSESSED 15 MINUTES LATER. THE LINE WAS STILL DAMP AND NOTED TO BE LEAKING AND THERE WERE BUBBLES OF FLUID FROM THE LINE. THE LINE LEAKED 2CM FROM THE STATLOCK ON THE ACTUAL CONTINUOUS PICC LINE, NOT THE EXTENSION SET OF LINE. THE LINE WAS RE-THREADED WITHOUT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18005075 ↗
• DeathAug 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT AT 20:30 ON (B)(6) 2020 THEY WERE NOTIFIED THAT AN INFANT'S PICC LINE WAS LEAKING. IT WAS DETERMINED THAT THE CATHETER ITSELF WAS LEAKING NECESSITATING REMOVAL. THE REGISTERED NURSE THEN MENTIONED THAT THEY THOUGHT THE LINE MAY HAVE BEEN LEAKING THE NIGHT BEFORE BUT WERE UNSURE IF IT WAS IV FLUID OR URINE IN THE BED. THE INFANT HAD ALMOST NO URINE OUTPUT THROUGHOUT THE DAY ON (B)(6) 2020 AND HAD INCREASED BUN AND CREATININE. IT SEEMS LIKELY THAT THE MALE PATIENT RECEIVED SOME BUT CERTAINLY NOT ALL OF THE FLUID THAT HE SHOULD HAVE IN THE PAST 24 HOURS RESULTING IN ANURIA AND POOR RENAL PERFUSION. ADDITIONAL INFORMATION RECEIVED ON 31JUL2023 STATED THAT THE PATIENT REQUIRED FLUID RESUSCITATION INCLUDING A FLUID BOLUS AND INCREASING HIS TOTAL FLUID VOLUME FOR THE DAY. THE PATIENT PASSED AWAY THE DAY AFTER THE PICC WAS FOUND TO BE LEAKING. CAUSE OF DEATH WAS UNDETERMINED IN THE CHART. HE WAS BORN EXTREMELY PREMATURE.

  Patient problems: Renal Impairment

  MAUDE report 17452272 ↗
• MalfunctionAug 3, 2023Crack; Crack

  THE CUSTOMER REPORTED THAT THE PICC LINE CATHETER FOUND TO BE LEAKING THROUGH A CRACK/HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451360 ↗
• MalfunctionJun 7, 2023Fracture; Fracture

  THE CUSTOMER REPORTED THAT A FRACTURE WAS OBSERVED BETWEEN THE BUTTERFLY AND BEGINNING OF THE CATHETER. THE CATHETER REMOVED. NO OTHER INFORMATION IS ABLE TO BE OBTAINED AS THE EVENT WAS REPORTED ANONYMOUSLY TO ANVISA IN BRAZIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080351 ↗
• MalfunctionJun 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS: THE PURPLE HUB ON THE PICC DISCONNECTED FROM THE CENTRAL LINE AND THE LINE SLIPPED OUT. THIS OCCURRED AT APPROXIMATELY 20.45 ON (B)(6) 2023. THE PATIENT WAS WITHOUT FLUIDS FOR 45 MINUTES AND HAD SOME BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17078976 ↗
• MalfunctionJan 24, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE NURSE WAS ASSESSING THE PATIENT AND NOTICED A SMALL DROP OF FLUID LEAK ON TO PATIENT'S ABDOMEN. UPON FURTHER ASSESSMENT, IT WAS NOTED THE PATIENT'S PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE IN THE RIGHT ACCESSORY CEPHALIC VEIN HAD A SMALL LEAK FROM THE LINE AS IF THERE WAS A CRACK IN THE LINE. CHARGE NURSE WAS NOTIFIED TO COME ASSESS AND NEONATAL NURSE PRACTITIONER (NNP) WAS CALLED. NNP ORDERED PICC LINE TO BE REMOVED. CHARGE NURSE REMOVED THE LINE, STARTED A PERIPHERAL INTRAVENOUS LINE (PIV), AND RESTARTED FLUIDS, 1X DOSE OF VANCOMYCIN GIVEN PER NNP ORDER. PER ADDITIONAL INFORMATION PROVIDED ON JANUARY 18, 2023, THE VANCOMYCIN WAS GIVEN PROPHYLACTICALLY BECAUSE THE CENTRAL LINE WAS COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16236145 ↗
• MalfunctionJan 12, 2023Break; Break

  THE CUSTOMER REPORTED THE PICC LINE WAS PLACED ON MONDAY (B)(6). ON TUESDAY (B)(6) THE NURSE WHO PLACED THE PICC CAME TO CHANGE THE DRESSING AND FOUND IT WAS BROKEN IN HALF. THE PICC WAS URGENTLY REMOVED AND INCIDENT REPORTED TO LEADERSHIP. ADDITIONAL INFORMATION RECEIVED: THE DEVICE BROKE OUTSIDE THE PATIENT'S BODY. THE PICC HAD SOME LENGTH BETWEEN THE INSERTION SITE AND THE SPOT WHERE IT BROKE SO IT WAS GENTLY PULLED OUT BY THE REMAINING PART OF THE PICC OUTSIDE THE BODY. NO REPLACEMENT WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16146172 ↗
• MalfunctionSep 29, 2022Fluid/Blood Leak; Separation Problem; Fluid/Blood Leak; Separation Problem

  CUSTOMER REPORTS A FAILURE OF THE PICC CATHETER. PER ADDITIONAL INFORMATION RECEIVED ON 09/19/22, A BREAKAGE AND LEAKING OCCURRED JUST BELOW THE BUTTERFLY WHERE THE CATHETER IS JOINED. CHLOROHEXADINE WAS USED TO CLEAN THE AREA PRIOR TO INSERTION, IT WAS THEN SECURED WITH SECUREPORT IV ADHESIVE & SORBAVION DRESSING. THE PRODUCT WAS INSERTED ON (B)(6) 2022 ON THE RIGHT UPPER EXTREMITY BASILIC AND REMOVED ON (B)(6) 2022. THE DEVICE WAS REPLACED WITH ANOTHER 1.9FR PICC LINE. THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15504034 ↗
• MalfunctionSep 27, 2022Break; Leak/Splash; Break; Leak/Splash

  THE CUSTOMER REPORTED THE FAILURE OF THE PICC. PER ADDITIONAL INFORMATION PROVIDED ON SEPTEMBER 23, 2022, THE PICC BROKE AND WAS LEAKING JUST BELOW THE BUTTERFLY WHERE THE CATHETER IS JOINED. THE LINE NEEDED TO BE REPLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15494547 ↗
• MalfunctionMar 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THEY WERE CHECKING THE PICC DRESSING AND NOTICED, RIGHT BELOW THE PURPLE BUTTERFLY, THE CATHETER NARROWS, AS IF IT HAS BEEN STRETCHED. THE DRESSING REMAINS OCCLUSIVE, THE CATHETER IS SECURE AND DOESN'T MOVE, AND THERE IS NO LEAKING OF ANY FLUID. ADDITIONAL INFORMATION RECEIVED STATED THE CATHETER SLIPPED OUT OF THE PURPLE BUTTERFLY HUB. THERE WAS NO MEDICAL INTERVENTION OTHER THAN THE PICC WAS REMOVED. PICC REPLACEMENT WAS ATTEMPTED BUT WAS UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13937834 ↗
• MalfunctionMar 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13896505 ↗
• MalfunctionMar 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT AFTER CHANGING THE END CAP, FLUID WAS NOTED TO BE SPRAYING OUT OF THE PICC LINE. THERE WAS NO LEAKING NOTED DURING FLUID ADMINISTRATION OR FLUID IN THE BED. THE PICC LINE WAS QUICKLY DISCONTINUED AND AN ADDITIONAL PIV WAS PLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13896501 ↗
• MalfunctionMar 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER STATED THAT THE BED WAS WET AND LEAKING WAS COMING FROM SOMEWHERE. SPECIFICS ARE UNKNOWN. THERE WAS NO INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13876022 ↗
• MalfunctionSep 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT UPON FIRST ASSESSMENT, BLOOD WAS FOUND BACKING UP INTO THE ARGYLE SINGLE-LUMEN PERIPHERAL INSERTED CENTRAL CATHETER (PICC) LINE. THE PICC LINE FELT WET AND THE LINEN UNDER THE INFANT WAS WET. THE TREATMENT WAS PAUSED AND THEY DISCONNECTED THE IV FLUIDS AND FLUSHED THE LINE WITH NORMAL SALINE. FLUID SQUIRTED OUT OF THE SIDE OF THE PICC LINE. AFTER CONSULTING WITH THE HEALTH CARE PROVIDERS, THE PICC LINE WAS PULLED AND A NEW PERIPHERAL INTRAVENOUS LINE WAS INSERTED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12440943 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 8/31/21 PICC#2: INSERTED ON (B)(6) 2021 AT 5 PM. FIRST ATTEMPT ON THAT EXTREMITY, NO DIFFICULTY IN INSERTING THE LINE. APPEARED TO BE IN SVC ON XRAY. LINE INFILTRATED AT MIDNIGHT WITHIN 7 HOURS. REPEAT XRAY SHOWED THE PICC TO BE IN SIMILAR POSITION, MODERATE PLEURAL EFFUSION. INFANT WITH RESPIRATORY COMPROMISE AND NECK EDEMA. HAD TO BE INTUBATED. LINE REMOVED.

  Patient problems: Pleural Effusion; Swelling/ Edema

  MAUDE report 12380791 ↗
• MalfunctionAug 3, 2021Backflow; Fluid/Blood Leak

  UPON FIRST ASSESSMENT, BLOOD WAS FOUND BACKING UP INTO THE ARGYLE SINGLE-LUMEN PERIPHERAL INSERTED CENTRAL CATHETER (PICC) LINE. THE PICC LINE FELT WET AND LINEN UNDER INFANT WET. THE TREATMENT WAS PAUSED AND DISCONNECTED IV FLUIDS AND FLUSHED LINE WITH NORMAL SALINE. FLUID SQUIRTED OUT OF THE SIDE OF THE PICC LINE. AFTER CONSULTING WITH THE HEALTH CARE PROVIDERS, THE PICC LINE PULLED AND A NEW PERIPHERAL INTRAVENOUS LINE INSERTED.

  Patient problems: Insufficient Information

  MAUDE report 12266240 ↗
• InjuryApr 20, 2021Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED THE REGISTERED NURSE (RN) WAS ATTEMPTING PLACEMENT OF A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE IN BABY'S RIGHT CEPHALIC VEIN. A SECOND RN WAS HOLDING THE BABY'S ARM STILL. THE RN WAS FEEDING THE CATHETER THROUGH THE INTRODUCER USING STERILE TWEEZERS, THREADING IT UP THE ARM, UNTIL IT MET RESISTANCE AT APPROXIMATELY THE LEVEL OF THE SHOULDER, ABOUT 8 CM. SHE THEN PULLED IT BACK ABOUT 2 CM AND AGAIN TRIED TO MAKE IT PAST THE SHOULDER, BUT AGAIN MET RESISTANCE. SHE THEN WENT TO PULL IT OUT COMPLETELY, BUT IT BECAME STUCK AT THE 13 CM MARK. BOTH THE RN AND A PHYSICIAN TRIED TO REMOVE THE CATHETER UNSUCCESSFULLY. AN X-RAY DONE AT THE BEDSIDE WAS SUGGESTIVE OF A KNOT IN THE CATHETER THAT WAS PREVENTING IT FROM BEING REMOVED. THE BABY WAS TAKEN TO THE OR THE FOLLOWING MORNING TO HAVE THE CATHETER REMOVED. PER THE OP NOTE, A SMALL SIMPLE KNOT WAS INITIALLY FOUND AND THIS WAS EASILY UNDONE. BUT FURTHER INTO THE SUBCUTANEOUS TISSUE THERE WAS A MUCH LARGER KNOT. THIS WAS CAREFULLY MANEUVERED OUT OF THE TISSUE AND THE EXIT SITE AND THEN THE REST OF THE CATHETER WAS REMOVED WITHOUT ANY FRAGMENTATION. THERE WAS NO BLEEDING. FLUOROSCOPY WAS AGAIN USED TO CONFIRM

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11696925 ↗
• InjuryDec 11, 2020Break; Break

  THE CUSTOMER REPORTED THAT A PIECE OF THE PICC BROKE OFF OF THE CATHETER INTO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10991992 ↗