ProGuide™ 00884450096413Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
All models of ProGuide (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450096413), received between Aug 14, 2024 and Aug 15, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Flow or Under Infusion1
- Pressure Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Reduced Blood Flow1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2024Pressure Problem; Pressure Problem
THE ACCOUNT ALLEGES THAT A FEMORAL HEMODIALYSIS CATHETER WAS IMPLANTED IN THE PATIENT. THE ACCOUNT ALLEGES THAT THE CATHETER IS NOT ALLOWING GOOD FLOW PRESSURES DURING THE DIALYSIS PROCEDURE EXTENDING DIALYSIS TIME FOR THE PATIENT. A NEW IJ CATHETER WAS PLACED AND THE PATIENT EXPERIENCED THE SAME LOW FLOW VALUES AGAIN. THE PATIENT RETURNED TO THE HOSPITAL FOR ANOTHER HEMODIALYSIS CATHETER THE NEXT DAY. THE HD CATHETER WAS EXCHANGED AND WAS FOUND TO BE OPERATING CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19997522 ↗MalfunctionAug 14, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
THE ACCOUNT ALLEGES THAT THE HEMODIALYSIS CATHETER WAS NOT PROVIDING GOOD FLOW. THE NEXT DAY THE CATHETER WAS CHANGED FOR A NEW ONE IN THE RIGHT JUGULAR AND IT IS CURRENTLY REPORTED TO BE FUNCTIONING CORRECTLY.
Patient problems: Reduced Blood Flow
MAUDE report 19981727 ↗
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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 14, 2026 · each report above links to its original FDA record
- 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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