ArgyleRecalls & reported problems across all models
Cardinal Health, Inc. · 64 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 459
- Deaths reported
- 6
- Injuries reported
- 51
- Recalls
- 0
We found 64 models of Argyle by Cardinal Health, Inc. in the FDA's device registry (GUDID). Together they are named in 459 adverse event reports in the FDA's MAUDE database, received between Nov 9, 2016 and Sep 17, 2026 — classified as 6 deaths, 51 injuries, 402 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (107 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Argyle problems
Device problems
- Fluid/Blood Leak107
- Break73
- Detachment of Device or Device Component57
- Explosion37
- Leak/Splash30
- Crack29
- Connection Problem19
- Material Separation15
Patient problems
- No Clinical Signs, Symptoms or Conditions209
- No Consequences Or Impact To Patient114
- No Known Impact Or Consequence To Patient37
- Foreign Body In Patient31
- Insufficient Information15
- No Patient Involvement9
- Hemorrhage/Blood Loss/Bleeding7
- No Information7
Argyle models
64 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Argyle 8888160333CATHETER, UMBILICAL ARTERY2 deaths66 reports
- Argyle MH00002TInfant heel warmer (chemical heat pack)53 reports
- Argyle 43304Catheter,intravascular,therapeutic,long-term greater than 30 days41 reports
- Argyle 8888160341CATHETER, UMBILICAL ARTERY36 reports
- Argyle 43303Catheter,intravascular,therapeutic,long-term greater than 30 days1 death34 reports
- Argyle 8888160531CATHETER, UMBILICAL ARTERY23 reports
- Argyle 8888160556CATHETER, UMBILICAL ARTERY1 death14 reports
- Argyle 8888301614TUBING, NONINVASIVE14 reports
- Argyle 8888570549CATHETER AND TIP, SUCTION1 death13 reports
- Argyle 43309Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days11 reports
- Argyle 8888301713TUBING, NONINVASIVE11 reports
- Argyle 8881450004Mouthpiece, saliva ejector9 reports
- Argyle 8888501015APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED9 reports
- Argyle 8888160408CATHETER, UMBILICAL ARTERY8 reports
- Argyle 8888256503CATHETERS, SUCTION, TRACHEOBRONCHIAL8 reports
- Argyle 8888256529CATHETERS, SUCTION, TRACHEOBRONCHIAL7 reports
- Argyle 8888561050Trocar5 reports
- Argyle 8888571059CATHETER AND TIP, SUCTION5 reports
- Argyle 461008EGastrointestinal Tubes with Enteral Specific Connectors5 reports
- Argyle 43201CATHETER, UMBILICAL ARTERY1 death5 reports
- Argyle 8888561068Trocar4 reports
- Argyle 460802EGastrointestinal Tubes with Enteral Specific Connectors4 reports
- Argyle 36626CATHETER AND TIP, SUCTION4 reports
- Argyle 8888160648CATHETER, UMBILICAL ARTERY4 reports
- Argyle 8888514604ACCESSORIES, CATHETER3 reports
- Argyle 8888750018CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION3 reports
- Argyle 460604EGastrointestinal Tubes with Enteral Specific Connectors3 reports
- Argyle 5558301627TUBING, NONINVASIVE3 reports
- Argyle 8888301523TUBING, NONINVASIVE3 reports
- Argyle 8888509703CATHETER AND TIP, SUCTION3 reports
- Argyle 8888505040APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED3 reports
- Argyle 8888256503CATHETERS, SUCTION, TRACHEOBRONCHIAL3 reports
- Argyle 8888160325CATHETER, UMBILICAL ARTERY3 reports
- Argyle 8888560805Trocar2 reports
- Argyle 460802Tubes, Gastrointestinal (And Accessories)2 reports
- Argyle 8888301606TUBING, NONINVASIVE2 reports
- Argyle 8888501023APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED2 reports
- Argyle 8888501031APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED2 reports
- Argyle 8888572552CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY2 reports
- Argyle 43311Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2 reports
- Argyle 8886864604CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION2 reports
- Argyle 8888572545CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY1 report
- Argyle 8888572560CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY1 report
- Argyle 8888573048CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY1 report
- Argyle 8888561019Trocar1 report
- Argyle 8888570507CATHETER AND TIP, SUCTION1 report
- Argyle 8888570523CATHETER AND TIP, SUCTION1 report
- Argyle 8888570572CATHETER AND TIP, SUCTION1 report
- Argyle 8888571034CATHETER AND TIP, SUCTION1 report
- Argyle 460208EGastrointestinal Tubes with Enteral Specific Connectors1 report
- Argyle 460711EGastrointestinal Tubes With Enteral Specific Connectors1 report
- Argyle 461206EGastrointestinal Tubes with Enteral Specific Connectors1 report
- Argyle 31400CATHETER AND TIP, SUCTION1 report
- Argyle 8888284703TUBING, NONINVASIVE1 report
- Argyle 8888301507TUBING, NONINVASIVE1 report
- Argyle 8888301515TUBING, NONINVASIVE1 report
- Argyle 8888301531TUBING, NONINVASIVE1 report
- Argyle 8888301622TUBING, NONINVASIVE1 report
- Argyle 8888301721TUBING, NONINVASIVE1 report
- Argyle 5558502000APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 report
- Argyle 8888501007APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 report
- Argyle 8888301705TUBING, NONINVASIVE1 report
- Argyle 8888160358CATHETER, UMBILICAL ARTERY1 report
- Argyle MH00002NInfant heel warmer (chemical heat pack)1 report
Recent Argyle adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Leak/Splash
Patient problems: Hypoglycemia
MAUDE report 50809825 ↗MalfunctionAug 7, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50177979 ↗MalfunctionMay 26, 2026Material Separation
THE CUSTOMER REPORTED THEY NEEDED A FEEDING TUBE AND WHEN GRABBING THIS FEEDING TUBE THE WRITER NOTICED THAT THE TIP LOOKED FLAT/PINCHED. AFTER INSPECTING IT FURTHER, IT IS NOT THE LENGTH THAT IT SHOULD BE, THE LAST FEW CENTIMETERS ARE NOT THERE. IT IS CUT OFF AT THE 8 CM MARK AND FLATTENED. THE WRITER OPENED THE PACKAGE, ATTACHED AN ENFIT SYRINGE AND TRIED TO PASS AIR THROUGH THE TUBING, NO AIR OR FLUID CAN PASS THROUGH THE TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25281937 ↗MalfunctionApr 23, 2026Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE SUCTION TUBE BLUE CONNECTOR/ADAPTOR DISCONNECTED. THERE WAS NO REPORTED PATIENT USE OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24967872 ↗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 ↗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 ↗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 23, 2026Break
THE CUSTOMER REPORTED THE TIP APPEARED TO BE CHIPPED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24423016 ↗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 24, 2025Break; Break
THE CUSTOMER REPORTED THAT 3.5FR SINGLE LUMEN CATHETER WAS DROPPED ON TO THE STERILE FIELD. IT WAS NOTED THAT THE END OF CATHETER WHERE THE STOPCOCK WOULD BE CONNECTED HAD BROKEN OFF. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888242 ↗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 ↗
Other Cardinal Health, Inc. products
- Kangaroo145 models · 4,461 reports
- Monoject164 models · 701 reports · 7 recalls
- Dover90 models · 226 reports · 12 recalls
- Magellan29 models · 445 reports
- Salem Sump28 models · 92 reports · 3 recalls
- Vistec8 models · 141 reports · 1 recall
- Kendall SCD12 models · 118 reports
- Kendall35 models · 58 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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