ProGuide™ 00884450029732Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450029732), received between Dec 8, 2020 and Jul 29, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult to Insert” (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
- Difficult to Insert1
- Fracture1
- Material Fragmentation1
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2025Difficult to Insert; Difficult to Insert
THE ACCOUNT ALLEGES DURING THE PROCEDURE FOR IMPLANTATION OF A PERMANENT CATHETER IN THE RIGHT INTERNAL JUGULAR VEIN, THE PATIENT EXPERIENCED A COMPLICATION RELATED TO THE MEDICAL DEVICE. AS A RESULT, THE PROCEDURE WAS SUSPENDED AND THE CATHETER WAS REMOVED. DUE TO THE COMPLEXITY OF THE VASCULAR ACCESS, THE PATIENT WAS URGENTLY REFERRED TO INTERVENTIONAL RADIOLOGY.
Patient problems: Failure of Implant
MAUDE report 22647402 ↗InjuryDec 8, 2020Fracture; Material Fragmentation; Fracture; Material Fragmentation
THE ACCOUNT ALLEGES THAT DURING DIALYSIS CATHETER EXCHANGE, THE CATHETER FRACTURED IN SEVERAL PLACES DURING THE REMOVAL. THE PHYSICIAN HAD TO CUT DOWN IN ORDER TO RETRIEVE THE DEVICE FROM THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 10971796 ↗
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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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