SKATER Drainage CatheterRecalls & reported problems across all models
Argon Medical Devices, Inc. · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 5 models of SKATER Drainage Catheter by Argon Medical Devices, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2021 and Jul 2, 2025 — classified as 2 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (18 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 SKATER Drainage Catheter problems
Device problems
- Fluid/Blood Leak18
- Break2
- Leak/Splash2
- Physical Resistance/Sticking2
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Insufficient Information9
- Foreign Body In Patient1
- Pneumothorax1
SKATER Drainage Catheter models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SKATER™ Drainage Catheter 755108035ECatheter, Continuous Irrigation17 reports
- SKATER™ Drainage Catheter 755108025ECatheter, Continuous Irrigation3 reports
- SKATER™ Drainage Catheter 751108025ECatheter, Continuous Irrigation1 report
- SKATER™ Drainage Catheter 755106025ECatheter, Continuous Irrigation1 report
- SKATER™ Drainage Catheter 755114025ECatheter, Continuous Irrigation1 report
Recent SKATER Drainage Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 2, 2025Leak/Splash; Leak/Splash
REPORTER INDICATED "LEAK". IT WAS REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Insufficient Information
MAUDE report 22383536 ↗InjuryMar 14, 2025Break; Break
DURING A DRAINAGE MANAGEMENT OF THE THORATIC CAVITY, THE PIGTAIL HAD BEEN PLACED IN VIVO FOR ABOUT 8¿9 DAYS WHEN THE DOCTOR FOUND THAT IT HAD BROKEN INTO TWO PIECES FROM THE WHITE HUB, CAUSING THE PATIENT TO DEVELOP PNEUMOTHORAX. THE PATIENT WAS THEN PLACED IN A CHEST TUBE AND TRANSFERRED TO THE ICU CARE. THE FAULTY PRODUCT RETURNED FROM THE HOSPITAL INCLUDED ONLY THE PIGTAIL AND WAS FOUND WITHOUT AN OUTER PACKAGE. WE HAVE PROVIDED A PHOTO FOR YOUR REFERENCE TO SHOW THE FAULTY CONDITION.
Patient problems: Pneumothorax
MAUDE report 21610375 ↗MalfunctionNov 22, 2024Fluid/Blood Leak; Fluid/Blood Leak
DURING THE PERCUTANEOUS NEPHROSTOMY PROCEDURE, THE DOCTOR FOUND THAT THE PIGTAIL'S SUTURE SLEEVE AND SUTURE STRINGS WERE LEAKING BODILY FLUIDS. THIS LEAKAGE ISSUE MADE THE DOCTOR VERY ANGRY BECAUSE IT KEPT OCCURRING CONTINUOUSLY, FORCING THE DOCTOR TO REPLACE THE PIGTAIL TO SOLVE THE PROBLEM. ADDITIONALLY, IT CAUSED FURTHER HARM TO THE PATIENT. OUR CUSTOMERS BELIEVE THAT ARGON MEDICAL DOES NOT VALUE THIS FEEDBACK, WHICH IS WHY THIS POOR EXPERIENCE OCCURS REPEATEDLY EVERY MONTH. THE FAULTY PRODUCT RETURNED FROM THE HOSPITAL INCLUDED ONLY THE PIGTAIL, WHICH WAS FOUND TO BE CUT INTO TWO PIECES. A VIDEO WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20762452 ↗MalfunctionMay 3, 2024Leak/Splash; Leak/Splash
THE REPORTER INDICATED THAT FOLLOWING A PERCUTANEOUS NEPHROSTOMY PROCEDURE, AND THE PATIENT RETURNING HOME, THE PIGTAIL'S WHITE CONNECTOR HUB LEAKED CAUSING THE PATIENT'S CLOTHES TO BECOME WET. THE PATIENT RETURNED TO THE HOSPITAL AGAIN TO SOLVE THE LEAKED SITUATION. THE DOCTOR STATED THE PIGTAIL LEAKING ISSUE CONTINUED TO OCCUR AND HAD ALREADY USED THE PURPLE LUER BUT DID NOT STOP THE LEAKING, THEY HAD NO CHOICE BUT TO REPLACE A NEW PIGTAIL TO SOLVE THE PROBLEM.
Patient problems: Insufficient Information
MAUDE report 19240311 ↗MalfunctionApr 11, 2024Fluid/Blood Leak; Fluid/Blood Leak
A REPORTER INDICATED THERE WAS LEAKAGE FROM THE HUB AFTER FINISHED CASE. THE TREATMENT PROCESS WAS COMPLETED, BUT THE AREA WHERE THE THREAD CAME OUT LEAKED, SO HAD TO RE-TREAT IT WITH A DIFFERENT PRODUCT.
Patient problems: Insufficient Information
MAUDE report 19087657 ↗MalfunctionJun 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
PHYSICIAN REPORTS THAT IN THE CONNECTOR OF THE IMPLANTED CATHETER, THROUGH THE HOLE WHERE ITS ANCHOR THREAD PASSES, THE LIQUID THAT THE CATHETER IS DRAINING ALSO COMES OUT; BECAUSE THAT OUTLET HOLE IS NOT WELL SEALED AND THE INTERNAL VALVE OF THE CATHETER DOES NOT WORK EITHER. THE RESULT IS THAT THE DOCTOR MUST CHANGE THE CATHETER AND IS A DANGER BECAUSE OF THE GREAT POSSIBILITY OF INFECTIONS OF THE AREA WHERE THE CATHETER COMES OUT. OBTAINING SAMPLES FROM THE FAILED CATHETERS EXPLANTED IS PRACTICALLY IMPOSSIBLE DUE TO THE GREAT POSSIBILITY OF DANGEROUS BIOCONTAMINATION DURING THE HANDLING OF THE RESCUED DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17052604 ↗MalfunctionJun 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
PHYSICIAN REPORTS THAT IN THE CONNECTOR OF THE IMPLANTED CATHETER, THROUGH THE HOLE WHERE ITS ANCHOR THREAD PASSES, THE LIQUID THAT THE CATHETER IS DRAINING ALSO COMES OUT; BECAUSE THAT OUTLET HOLE IS NOT WELL SEALED AND THE INTERNAL VALVE OF THE CATHETER DOES NOT WORK EITHER. THE RESULT IS THAT THE DOCTOR MUST CHANGE THE CATHETER AND IS A DANGER BECAUSE OF THE GREAT POSSIBILITY OF INFECTIONS OF THE AREA WHERE THE CATHETER COMES OUT. OBTAINING SAMPLES FROM THE FAILED CATHETERS EXPLANTED IS PRACTICALLY IMPOSSIBLE DUE TO THE GREAT POSSIBILITY OF DANGEROUS BIOCONTAMINATION DURING THE HANDLING OF THE RESCUED DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17052475 ↗MalfunctionJun 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
PHYSICIAN REPORTS THAT IN THE CONNECTOR OF THE IMPLANTED CATHETER, THROUGH THE HOLE WHERE ITS ANCHOR THREAD PASSES, THE LIQUID THAT THE CATHETER IS DRAINING ALSO COMES OUT; BECAUSE THAT OUTLET HOLE IS NOT WELL SEALED AND THE INTERNAL VALVE OF THE CATHETER DOES NOT WORK EITHER. THE RESULT IS THAT THE DOCTOR MUST CHANGE THE CATHETER AND IS A DANGER BECAUSE OF THE GREAT POSSIBILITY OF INFECTIONS OF THE AREA WHERE THE CATHETER COMES OUT. OBTAINING SAMPLES FROM THE FAILED CATHETERS EXPLANTED IS PRACTICALLY IMPOSSIBLE DUE TO THE GREAT POSSIBILITY OF DANGEROUS BIOCONTAMINATION DURING THE HANDLING OF THE RESCUED DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17052297 ↗MalfunctionJun 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
PHYSICIAN REPORTS THAT IN THE CONNECTOR OF THE IMPLANTED CATHETER, THROUGH THE HOLE WHERE ITS ANCHOR THREAD PASSES, THE LIQUID THAT THE CATHETER IS DRAINING ALSO COMES OUT; BECAUSE THAT OUTLET HOLE IS NOT WELL SEALED AND THE INTERNAL VALVE OF THE CATHETER DOES NOT WORK EITHER. THE RESULT IS THAT THE DOCTOR MUST CHANGE THE CATHETER AND IS A DANGER BECAUSE OF THE GREAT POSSIBILITY OF INFECTIONS OF THE AREA WHERE THE CATHETER COMES OUT. OBTAINING SAMPLES FROM THE FAILED CATHETERS EXPLANTED IS PRACTICALLY IMPOSSIBLE DUE TO THE GREAT POSSIBILITY OF DANGEROUS BIOCONTAMINATION DURING THE HANDLING OF THE RESCUED DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17052130 ↗MalfunctionJun 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
PHYSICIAN REPORTS THAT IN THE CONNECTOR OF THE IMPLANTED CATHETER, THROUGH THE HOLE WHERE ITS ANCHOR THREAD PASSES, THE LIQUID THAT THE CATHETER IS DRAINING ALSO COMES OUT; BECAUSE THAT OUTLET HOLE IS NOT WELL SEALED AND THE INTERNAL VALVE OF THE CATHETER DOES NOT WORK EITHER. THE RESULT IS THAT THE DOCTOR MUST CHANGE THE CATHETER AND IS A DANGER BECAUSE OF THE GREAT POSSIBILITY OF INFECTIONS OF THE AREA WHERE THE CATHETER COMES OUT. OBTAINING SAMPLES FROM THE FAILED CATHETERS EXPLANTED IS PRACTICALLY IMPOSSIBLE DUE TO THE GREAT POSSIBILITY OF DANGEROUS BIOCONTAMINATION DURING THE HANDLING OF THE RESCUED DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17051135 ↗MalfunctionJun 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
PHYSICIAN REPORTS THAT IN THE CONNECTOR OF THE IMPLANTED CATHETER, THROUGH THE HOLE WHERE ITS ANCHOR THREAD PASSES, THE LIQUID THAT THE CATHETER IS DRAINING ALSO COMES OUT; BECAUSE THAT OUTLET HOLE IS NOT WELL SEALED AND THE INTERNAL VALVE OF THE CATHETER DOES NOT WORK EITHER. THE RESULT IS THAT THE DOCTOR MUST CHANGE THE CATHETER AND IS A DANGER BECAUSE OF THE GREAT POSSIBILITY OF INFECTIONS OF THE AREA WHERE THE CATHETER COMES OUT. OBTAINING SAMPLES FROM THE FAILED CATHETERS EXPLANTED IS PRACTICALLY IMPOSSIBLE DUE TO THE GREAT POSSIBILITY OF DANGEROUS BIO-CONTAMINATION DURING THE HANDLING OF THE RESCUED DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17051030 ↗MalfunctionJun 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
PHYSICIAN REPORTS THAT IN THE CONNECTOR OF THE IMPLANTED CATHETER, THROUGH THE HOLE WHERE ITS ANCHOR THREAD PASSES, THE LIQUID THAT THE CATHETER IS DRAINING ALSO COMES OUT; BECAUSE THAT OUTLET HOLE IS NOT WELL SEALED AND THE INTERNAL VALVE OF THE CATHETER DOES NOT WORK EITHER. THE RESULT IS THAT THE DOCTOR MUST CHANGE THE CATHETER AND IS A DANGER BECAUSE OF THE GREAT POSSIBILITY OF INFECTIONS OF THE AREA WHERE THE CATHETER COMES OUT. OBTAINING SAMPLES FROM THE FAILED CATHETERS EXPLANTED IS PRACTICALLY IMPOSSIBLE DUE TO THE GREAT POSSIBILITY OF DANGEROUS BIOCONTAMINATION DURING THE HANDLING OF THE RESCUED DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17050842 ↗MalfunctionJun 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
PHYSICIAN REPORTS THAT IN THE CONNECTOR OF THE IMPLANTED CATHETER, THROUGH THE HOLE WHERE ITS ANCHOR THREAD PASSES, THE LIQUID THAT THE CATHETER IS DRAINING ALSO COMES OUT; BECAUSE THAT OUTLET HOLE IS NOT WELL SEALED AND THE INTERNAL VALVE OF THE CATHETER DOES NOT WORK EITHER. THE RESULT IS THAT THE DOCTOR MUST CHANGE THE CATHETER AND IS A DANGER BECAUSE OF THE GREAT POSSIBILITY OF INFECTIONS OF THE AREA WHERE THE CATHETER COMES OUT. OBTAINING SAMPLES FROM THE FAILED CATHETERS EXPLANTED IS PRACTICALLY IMPOSSIBLE DUE TO THE GREAT POSSIBILITY OF DANGEROUS BIOCONTAMINATION DURING THE HANDLING OF THE RESCUED DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17050668 ↗MalfunctionJun 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
PHYSICIAN REPORTS THAT IN THE CONNECTOR OF THE IMPLANTED CATHETER, THROUGH THE HOLE WHERE ITS ANCHOR THREAD PASSES, THE LIQUID THAT THE CATHETER IS DRAINING ALSO COMES OUT; BECAUSE THAT OUTLET HOLE IS NOT WELL SEALED AND THE INTERNAL VALVE OF THE CATHETER DOES NOT WORK EITHER. THE RESULT IS THAT THE DOCTOR MUST CHANGE THE CATHETER AND IS A DANGER BECAUSE OF THE GREAT POSSIBILITY OF INFECTIONS OF THE AREA WHERE THE CATHETER COMES OUT. OBTAINING SAMPLES FROM THE FAILED CATHETERS EXPLANTED IS PRACTICALLY IMPOSSIBLE DUE TO THE GREAT POSSIBILITY OF DANGEROUS BIOCONTAMINATION DURING THE HANDLING OF THE RESCUED DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17050505 ↗MalfunctionJun 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
PHYSICIAN REPORTS THAT IN THE CONNECTOR OF THE IMPLANTED CATHETER, THROUGH THE HOLE WHERE ITS ANCHOR THREAD PASSES, THE LIQUID THAT THE CATHETER IS DRAINING ALSO COMES OUT; BECAUSE THAT OUTLET HOLE IS NOT WELL SEALED AND THE INTERNAL VALVE OF THE CATHETER DOES NOT WORK EITHER. THE RESULT IS THAT THE DOCTOR MUST CHANGE THE CATHETER AND IS A DANGER BECAUSE OF THE GREAT POSSIBILITY OF INFECTIONS OF THE AREA WHERE THE CATHETER COMES OUT. OBTAINING SAMPLES FROM THE FAILED CATHETERS EXPLANTED IS PRACTICALLY IMPOSSIBLE DUE TO THE GREAT POSSIBILITY OF DANGEROUS BIOCONTAMINATION DURING THE HANDLING OF THE RESCUED DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17050369 ↗
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
- 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
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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