SafeSheath CSG 00884450484340Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of SafeSheath CSG (5)
Data updated Oct 18, 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450484340), received between Feb 15, 2023 and Feb 15, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
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 18, 2026.
Recalls naming this device
- Jun 11, 2024Class IIOpen, Classified
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-2571-2024 · Root cause: No Marketing Application · Recall details · FDA record ↗
Most reported problems
Device problems
- Fracture2
- Material Separation2
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.
InjuryFeb 15, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT CORONARY SINUS GUIDE BROKE WITHIN THE PATIENT. DURING ACCESS AT THE AXILLARY, THE TIP DETACHED AND THE DEVICE WAS NOT ABLE TO BE REMOVED FROM THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 16383885 ↗InjuryFeb 15, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT CORONARY SINUS GUIDE BROKE WITHIN THE PATIENT. DURING ACCESS AT THE AXILLARY, THE TIP DETACHED AND THE DEVICE WAS REMOVED BY HAND. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16383884 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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