Skater™ Fix 802500001Recalls & reported problems
Argon Medical Devices, Inc. · Skater™ Fix · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886333217618), received between Jan 17, 2023 and Mar 18, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- No Apparent Adverse Event1
- Patient Device Interaction Problem1
- Patient-Device Incompatibility1
Patient problems
- Skin Inflammation/ Irritation2
- Blister1
- Pain1
- Skin Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
THE USER OF THE DEVICE REPORTS AN ALLERGIC REACTION THAT STARTED FROM USING THE PRODUCT. LATER THE REACTION DEVELOPED IN AN INFECTION AND WAS TREATED. THE USER DOES NOT HAVE THE DEVICE ANYMORE BUT PROVIDED PICTURES OF THE SKIN REACTION.
Patient problems: Skin Infection
MAUDE report 21634210 ↗MalfunctionJul 6, 2024Difficult to Remove; Difficult to Remove
WHEN THE OPERATOR WILL REMOVE THE SKATER¿ FIX CATHETER FIXATION DEVICE FROM THE PATIENT'S SKIN, THEY FOUND IT WAS HARD TO REMOVE AND THEY TRIED TO SLOWLY AND GENTLY AND CAREFULLY, BUT STILL CAUSE THE PATIENT REDNESS, PAIN AND SKIN DEFECT SO THEY SUSPECT IT WAS A FAULTY PRODUCT. THE RETURNED OF THE FAULTY PRODUCT FROM THE HOSPITAL.
Patient problems: Pain; Skin Inflammation/ Irritation
MAUDE report 19685893 ↗InjuryJan 17, 2023Patient-Device Incompatibility; No Apparent Adverse Event; No Apparent Adverse Event
THE CUSTOMER WONDER IF WE HAVE MADE ANY CHANGES TO OUR SKATEFIX? THEY HAD 6 PATIENTS THAT HAVE RECEIVED BLISTERS AND BECOME VERY RED UNDER THE SKATERFIX AFTER A COUPLE OF WEEKS. THERE WAS NO LEAKAGE FROM THE NEPHROSTOMY. THIS HAVE HAPPENED DURING THE LAST TWO MONTH( NOV/ DEC) HAVE WE CHANGE ANYTHING IN PRODUCTION?
Patient problems: Blister; Skin Inflammation/ Irritation
MAUDE report 16186187 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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