First PICC S/L Peripherally Inserted Central CatheterRecalls & reported problems across all models
Argon Medical Devices, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 174
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 5 models of First PICC S/L Peripherally Inserted Central Catheter by Argon Medical Devices, Inc. in the FDA's device registry (GUDID). Together they are named in 174 adverse event reports in the FDA's MAUDE database, received between Apr 16, 2018 and May 29, 2026 — classified as 12 injuries, 162 malfunctions.
The most frequently reported specific device problem is “Break” (71 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 First PICC S/L Peripherally Inserted Central Catheter problems
Device problems
- Break71
- Fluid/Blood Leak31
- Material Rupture19
- Leak/Splash14
- Material Puncture/Hole9
- Physical Resistance/Sticking9
- Crack7
- Adverse Event Without Identified Device or Use Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions81
- Insufficient Information49
- No Known Impact Or Consequence To Patient18
- Extravasation8
- Foreign Body In Patient4
- Thrombus3
- Edema2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
First PICC S/L Peripherally Inserted Central Catheter models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- First PICC™ S/L Peripherally Inserted Central Catheter 384232Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days151 reports
- First PICC™ S/L Peripherally Inserted Central Catheter 384101Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days8 reports
- First PICC™ S/L Peripherally Inserted Central Catheter 384157Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days7 reports
- First PICC™ S/L Peripherally Inserted Central Catheter 384156Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days6 reports
- First PICC™ S/L Peripherally Inserted Central Catheter 384158Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days2 reports
Recent First PICC S/L Peripherally Inserted Central Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2026Break
THE INFANT WAS HAVING ITS VITALS TAKEN AND BEING REPOSITIONED. THE NURSE SAW IT SNAP [AT THE HUB], GRABBED IT AND HAD THE MEDICAL TEAM ATTEND THE BEDSIDE TO REMOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25337648 ↗InjuryMay 3, 2026Leak/Splash
¿DRESSING ON PICC NOTED TO BE WET. BOTH COTTON BALLS AND STERI STRIPS WERE WET. UNDER THE TEGADERM DRESSING WAS DRY. NNP NOTIFIED. UPON NNP ASPIRATING OFF THE LINE, FLUIDS NOTED TO BE LEAKING FROM THE THICKENED PART OF THE PICC ABOVE THE HUBB. PICC DC'D AND PERIPHERAL LINE PLACED. ONCE PICC REMOVED, FLUIDS WERE FLUSHED THROUGH THE CATHETER AND A SPLIT WAS NOTED IN THE CATHETER WITH FLUIDS LEAKING. CATHETER SAVED. DATE OF INSERTION ¿ (B)(6) 2026. PIV PLACED TO CONTINUE THERAPY.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062550 ↗MalfunctionJan 2, 2026Break
PICC WAS IN PLACE AND BABY WAS BEING HANDLED. PICC WAS NOT BEING ACCESSED AT THE TIME, BUT BROKE DURING THE HANDLE. THIS IS THE THIRD TIME THE SITE HAS REPORTED THIS FAILURE MODE FOR THIS LOT. THE PICC WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 23951820 ↗MalfunctionDec 12, 2025Break; Break
A NURSE REPORTED "A PICC SNAPPED UNDER THE DRESSING.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23791446 ↗InjuryNov 30, 2025Break; Break
A NURSE FOUND A PUDDLE OF IV FLUID ON THE FLOOR AND NOTICED THE SINGLE LUMEN PICC WAS NO LONGER COMPLETED/CONNECTED TO THE INSERTION SITE (RIGHT FOREARM). PICC WAS STILL IN-SITU, BUT UPON INSPECTION, RN NOTICED THAT THE PICC HAD SNAPPED/DETACHED FURTHER UP. MD ATTENDED TO REMOVE PICC AND CONFIRMED THE ENTIRETY OF THE PICC HAD BEEN REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23677465 ↗InjuryOct 30, 2025Break; Break
PICC LINE FOUND TO BE BROKEN AT "ARGON DISC" - REMOVED IN ITS ENTIRETY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23432846 ↗InjuryOct 28, 2025Break; Break
REPORTER STATED THAT PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE THAT HAS BEEN PLACED ON 2025 WAS FOUND TO BE BROKEN BELOW THE HUB. PICC LINE REMOVED IN ENTIRETY. PATIENT REQUIRED NEW PICC LINE PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23407547 ↗MalfunctionOct 15, 2025Break; Break
"WE HAVE HAD TWO ARGON PICC LINES BREAK WHILE IN THE PATIENT AT THE HUB RECENTLY. ONE OF MY PICC NURSES THINKS IT IS RELATED TO THE DRESSING WE USE. WE HAVE BEEN USING A STAT LOCK BECAUSE IT HAS A LONGER LENGTH OF TIME NEEDED BETWEEN DRESSING CHANGES. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23292754 ↗InjuryAug 27, 2025Break; Break
WRITER NOTES: "PICC LINE SPONTANEOUSLY SNAPPED WHEN PLACED UNDER VERY LIGHT TENSION WHILE REPOSITIONING A PATIENT. PICC WAS INSERTED ON (B)(6) AND BROKE ON (B)(6) 2025. PICC WAS LOCATED IN THE LEFT ANKLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22904117 ↗InjuryJun 18, 2025Break; Break
DURING PLACEMENT OF A PICC, THE PICC BECAME MALPOSITIONED AND "FLIPPED TOWARDS THE SHOULDER." WHEN REPOSITIONING THE PICC WAS ATTEMPTED, THE PICC FRACTURED, AND ONLY 3CM OF THE CATHETER CAME OUT WHEN EXTRACTION WAS ATTEMPTED, LEAVING 28CM IN THE PATIENT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND TO THE CATH LAB DUE TO THE THROMBUS, OR THE PORTION THAT REMAINED IN THE BODY, IN THE PULMONARY ARTERY. THIS PORTION OF THE CATHETER WAS EVENTUALLY ABLE TO BE REMOVED AND IS STILL BEING EVALUATED BY PATHOLOGY AT HOSPITAL (AS OF (B)(6)2025). SAMPLE IS AVAILABLE.
Patient problems: Thrombosis/Thrombus
MAUDE report 22285535 ↗MalfunctionJun 16, 2025Leak/Splash; Leak/Splash
A CUSTOMER REPORTED "THE USER USED 3ML SYRINGE WITH NORMAL SALINE FOR FLUSHING AND LEAKAGE OCCURRED AFTER IT WAS USED ON THE 4TH DAY. NO LEAKAGE WAS OBSERVED DURING PRIMING THE CATHETER BEFORE USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22212627 ↗MalfunctionMay 13, 2025Material Rupture; Material Rupture
A CUSTOMER REPORTED A PICC RUPTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22010325 ↗MalfunctionFeb 26, 2025Break; Break
PICC SNAPPED WHILE IN A PATIENT AFTER 26 DAYS. IT SNAPPED JUST BELOW THE BD DISC, AND THE LINE WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT INCIDENT. DID NOT USE STATLOK AND THE LINE WAS VERY LOW ON THE BABY¿S ARM. MULTIPLE DRESSING CHANGES ON THIS PATIENT DURING THE 26 DAYS. WE WILL PICK UP THE BROKEN PICC AND SEND BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21472807 ↗InjuryFeb 18, 2025Break; Break
PICC LINE SNAPPED DURING ADJUSTMENT. DISCONTINUED. REQUIRED ADDITIONAL INTERVENTION OF NEW PICC LINE PLACEMENT TO COMPLETE PRESCRIBED THERAPY.
Patient problems: Insufficient Information
MAUDE report 21396813 ↗MalfunctionJan 7, 2025Difficult to Flush; Difficult to Flush
PICC STARTED READING HIGH PRESSURE ON THE IV PUMP AND CATHETER DID NOT ASPIRATE OR FLUSH. WHEN THE STAFF WERE ATTEMPTING TO FLUSH THE CATHETER THE CATHETER HUB WAS COLLAPSING ON ITSELF AND NOT ALLOWING THE FLUSH TO BE ADMINISTERED. THE PICC WAS IN LESS THAN 4 HOURS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21092563 ↗
Other Argon Medical Devices, Inc. products
- BioPince Ultra Full Core Biopsy Instrument10 models · 85 reports · 1 recall
- BioPince Full Core Biopsy Instrument5 models · 60 reports · 1 recall
- L-Cath PICC S/L2 models · 30 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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