ProGuide™ 00884450697221Recalls & 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 00884450697221), received between Feb 15, 2023 and Feb 16, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
THE ACCOUNT ALLEGES AFTER IMPLANTATION OF A PROGUIDE DIALYSIS CATHETER, THE CATHETER WAS FOUND TO BE CRACKED AND LEAKED BLOOD WHEN TRYING TO ACCESS THE DEVICE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16386488 ↗MalfunctionFeb 15, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DIALYSIS CATHETER WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2023. DURING THE PATIENT'S DIALYSIS PROCEDURE, THE MEDICAL STAFF NOTED THAT THE DIALYSIS CATHETERS HUB WAS CRACKED AND LEAKING BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16383295 ↗
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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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