ProGuide™ 00884450012536Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
All models of ProGuide (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450012536), received between Jul 24, 2024 and Aug 21, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Crack” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
- Fracture1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2024Fracture; Fracture
THE CUSTOMER ALLEGES THAT THE CATHETER DETACHED WITHIN THE PATIENT POST-PROCEDURE. A CHEST X-RAY WAS PERFORMED CONFIRMING CATHETER DETACHMENT AT THE LEVEL OF THE LEFT EDGE OF THE CARDIAC SILHOUETTE, HOSPITALIZING THE PATIENT FOR TWO DAYS UNTIL HIS HEALTH IMPROVED. THE PATIENT WAS TAKEN FOR FOREIGN BODY REMOVAL AND INSERTION OF A NEW DIALYSIS CATHETER ON (B)(6) 2024. ON (B)(6) 2024 HE WAS DISCHARGED WITH FAVORABLE EVOLUTION.
Patient problems: Foreign Body In Patient
MAUDE report 20015451 ↗MalfunctionJul 24, 2024Crack; Crack
THE ACCOUNT ALLEGES THAT THE CATHETER HUB CRACKED 8 MONTHS AFTER THE DIALYSIS CATHETER WAS IMPLANTED. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19821263 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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