Prelude SNAP™ T (REF PLS-1006)Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884450859800), received between Aug 27, 2025 and Aug 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- 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.
MalfunctionAug 27, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT THEY ARE UNABLE TO TEAR AWAY THE SPLITABLE SHEATH. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909988 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.