SafeSheath™ 00884450395943Recalls & reported problems
Merit Medical · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450395943), received between Feb 28, 2020 and Feb 28, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Material Deformation” (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.
Most reported problems
Device problems
- Material Deformation1
Patient problems
- Pseudoaneurysm1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 28, 2020Material Deformation; Material Deformation
THE ACCOUNT ALLEGES THAT DURING SEVERAL ATTEMPTS TO ACQUIRE PERCUTANEOUS VASCULAR ACCESS VIA THE PATIENT'S SUBCLAVIAN VEIN, A HEMATOMA AND A PSEUDOANEURYSM FORMED. THE PHYSICIAN WAS UNSUCCESSFUL IN ACQUIRING VENOUS ACCESS WITH THE GUIDEWIRE AND ACCESS NEEDLE. THE HEMATOMA WAS TREATED BY THE MEDICAL STAFF AND A VASCULAR STENT WAS EVENTUALLY PLACED BY THE PHYSICIAN TO SUCCESSFULLY TREAT THE PATIENT'S PSEUDOANEURYSM WITH NO ADDITIONAL CONSEQUENCES TO REPORT.
Patient problems: Pseudoaneurysm
MAUDE report 9772390 ↗
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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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