L-Cath PICC S/LRecalls & reported problems across all models
Argon Medical Devices, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one L-Cath PICC S/L model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 2 models of L-Cath PICC S/L by Argon Medical Devices, Inc. in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Mar 4, 2021 and May 8, 2025 — classified as 1 injury, 29 malfunctions.
The most frequently reported specific device problem is “Crack” (29 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
L-Cath PICC S/L recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 15, 2026Open, Classified
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
Z-2803-2026 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
Most reported L-Cath PICC S/L problems
Device problems
- Crack29
- Break6
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- Insufficient Information28
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
L-Cath PICC S/L models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- L-Cath PICC S/L 20 GA (3F) 1.0mm x 60cmCatheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days1 recall28 reports
- L-Cath™ PICC S/L 18GA (3.5F) 1.15mm x 60cmCatheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days1 recall2 reports
Recent L-Cath PICC S/L adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2025Crack; Leak/Splash; Crack; Leak/Splash
REPORTER STATES 7 PICCS FROM THIS LOT WERE CRACKED/LEAKING AT THE HUB.
Patient problems: Insufficient Information
MAUDE report 21990526 ↗MalfunctionMay 8, 2025Break; Crack; Break; Crack
THE REPORTER STATES THEY HAVE FOUND BROKEN/CRACKED PICCS FROM 4 DIFFERENT LOTS. NO DETAILS WERE PROVIDED ABOUT TYPE OF PROCEDURE, QUANTITY OF PICCS, DATES OF OCCURRENCE, NO INJURY WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 21990306 ↗MalfunctionMay 8, 2025Break; Crack; Break; Crack
THE REPORTER STATES THEY HAVE FOUND BROKEN/CRACKED PICCS FROM 4 DIFFERENT LOTS. NO DETAILS WERE PROVIDED ABOUT TYPE OF PROCEDURE, QUANTITY OF PICCS, DATES OF OCCURRENCE, NO INJURY WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 21990169 ↗MalfunctionMay 8, 2025Break; Crack; Break; Crack
THE REPORTER STATES THEY HAVE FOUND BROKEN/CRACKED PICCS FROM 4 DIFFERENT LOTS. NO DETAILS WERE PROVIDED ABOUT TYPE OF PROCEDURE, QUANTITY OF PICCS, DATES OF OCCURRENCE, NO INJURY WAS REPORTED,
Patient problems: Insufficient Information
MAUDE report 21990032 ↗MalfunctionMay 8, 2025Break; Crack; Break; Crack
THE REPORTER STATES THEY HAVE FOUND BROKEN/CRACKED PICCS FROM 4 DIFFERENT LOTS. NO DETAILS WERE PROVIDED ABOUT TYPE OF PROCEDURE, QUANTITY OF PICCS, DATES OF OCCURRENCE, NO INJURY WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 21989657 ↗MalfunctionJan 26, 2024Crack; Crack
INTERNAL HUB CRACKED AND NO FLUSHING WITHIN ONE DAY OF INSERTION (INSERTED IN MORNING, EVENT OCCURRED IN EVENING). DATE OF INSERTION: (B)(6) 2023 (<1 DAY IN SITU) PICC REMOVED AND REPLACED WITH NEW PICC.
Patient problems: Insufficient Information
MAUDE report 18586969 ↗InjuryJan 24, 2024Crack; Crack
PICC LINE DISCOVERED LEAKING BLOOD FROM CONNECTOR BETWEEN FEMALE AND OF PICC LINE AND LUER LOCK CONNECTOR FROM EXTENSION TUBING. DISCOVERED CRACK ON FEMALE END OF PICC LINE. DATE OF INSERTION: (B)(6) 2023 (IN SITU 5 DAYS) INJURY: UNDETERMINED AMOUNT OF BLOOD LOSS. INTERVENTION: PICC LINE REMOVED RESULTING IN LOSS OF TPN INFUSED AND UNDETERMINED AMOUNT OF BLOOD LOSS FROM DEFECTIVE PICC AREA. IV INSERTION INITIATED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18573283 ↗MalfunctionJul 31, 2023Break; Crack; Break; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. - A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL -A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. - A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. -PAIN RELATED TO THE INSTALLATION PROCEDURE. -THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. -A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17425646 ↗MalfunctionJul 31, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL. A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17425511 ↗MalfunctionJul 31, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17425440 ↗MalfunctionJul 31, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17425343 ↗MalfunctionJul 31, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17424121 ↗MalfunctionJul 31, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17424040 ↗MalfunctionJul 31, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17423928 ↗MalfunctionJul 28, 2023Crack; Crack
BROKEN CATHETER, THIS ONE CRACKING AT THE LEVEL OF THE PLASTIC JUNCTION. FOR THE MOMENT OUR BABIES ARE DOING WELL FOLLOWING THE INCIDENTS. BUT FROM THE PERSPECTIVE THAT OUR PREMATURE BABY, WHO IS BASICALLY A VERY FRAGILE BABY WITH NO IMMUNE DEFENCE, EACH INSTALLATION WHERE THE BREAKAGE OF THE CATHETERS HAS OCCURRED, WHICH HAS REQUIRED A 2ND OR EVEN A 3RD INSTALLATION, IS AN INJURY WHICH IS DIFFICULT TO JUSTIFIABLE AND THIS POSES SEVERAL MAJOR RISKS TO ITS FOLLOW-UP. THE DAMAGES ARE MANY. A DELAY IN TREATMENT (PARENTERAL NUTRITION AND ANTIBIOTICS, HEMODYNAMIC INSTABILITY) WHICH IS ESSENTIAL TO ITS SURVIVAL. A POTENTIAL RISK OF INFECTION RELATED TO MULTIPLE CATHETER CHANGES. A RISK OF DETERIORATION OF THE STATE OF HEALTH DURING INTRA-HOSPITAL TRANSPORT. PAIN RELATED TO THE INSTALLATION PROCEDURE. THE RISK OF WEIGHT LOSS AND HYPOGLYCEMIA. A MAJOR SOURCE OF STRESS FOR FAMILIES. (FRENCH TRANSLATED TO ENGLISH).
Patient problems: Insufficient Information
MAUDE report 17414564 ↗
Other Argon Medical Devices, Inc. products
- First PICC S/L Peripherally Inserted Central Catheter5 models · 174 reports
- BioPince Ultra Full Core Biopsy Instrument10 models · 85 reports · 1 recall
- BioPince Full Core Biopsy Instrument5 models · 60 reports · 1 recall
- Tru-Core II Biopsy Instrument8 models · 13 reports · 1 recall
- Scorpion2 models · 7 reports · 1 recall
- Arterial Line Kit2 models · 2 reports · 1 recall
- Tru-Core II URO Biopsy Instrument2 models · 2 reports · 1 recall
- Transvenous Pacing Electrode Tray2 models · 0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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