ProGuide™ 00884450697917Recalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450697917), received between May 30, 2023 and May 30, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Feb 13, 2026Open, Classified
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
Z-1576-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fracture1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT THE PHYSICIAN TRIED TO REMOVE THE SHEATH AFTER HE SPLIT THE CATHETER AND THE HUBS BROKE OFF WITH PART OF THE SHEATH ATTACHED. THE REST OF THE SHEATH AND OTHER SIDE OF THE HUB REMAINED IN THE PATIENT. THE PHYSICIAN WAS ABLE TO GET THE SHEATH OUT BY CAREFULLY CUTTING THE SHEATH WITH SCISSORS AS HE REMOVED SMALL AMOUNTS AT A TIME. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17027365 ↗
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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 · each recall links to the FDA recall notice
- 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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