SKATER™ Drainage Catheter 755108035ERecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00886333000166), received between May 4, 2023 and Nov 22, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (17 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 17050241 ↗
• 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. 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 17049872 ↗
• MalfunctionMay 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  SAME PROBLEM IS OCCURRING IN SEVERAL PATIENTS (12 AT LEAST): 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; ALTHOUGH THE HOSPITAL NEEDS FREE UNITS OF DEVICE FOR REPLACEMENTS FROM DIFFERENT LOTS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16871172 ↗
• MalfunctionMay 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  SAME PROBLEM IS OCCURRING IN SEVERAL PATIENTS (12 AT LEAST): 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; ALTHOUGH THE HOSPITAL NEEDS FREE UNITS OF DEVICE FOR REPLACEMENTS FROM DIFFERENT LOTS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16870984 ↗
• MalfunctionMay 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  SAME PROBLEM IS OCCURRING IN SEVERAL PATIENTS (12 AT LEAST): 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; ALTHOUGH THE HOSPITAL NEEDS FREE UNITS OF DEVICE FOR REPLACEMENTS FROM DIFFERENT LOTS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16869861 ↗