Advance Serenity™ 14 SER14-120-30-150Recalls & reported problems
Creagh Medical Limited · Advance Serenity 14 3mm x 15cm x 120cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 05391525784564), received between Oct 31, 2023 and Oct 31, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
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.
MalfunctionOct 31, 2023Fracture; Fracture
THE SITE REPORTED THE BALLOON RUPTURED. IT WAS ALSO NOTED THE GUIDEWIRE STUCK TO THE BALLOON. IT WAS ALSO NOTED THE BALLOON HAD POOR NAVIGABILITY. AFTER "DE-INFLATING", THE BALLOON RUPTURED. THE PHYSICIAN ALSO HAD DIFFICULTY REMOVING THE GUIDEWIRE FROM INSIDE THE BALLOON. REGARDING THE BALLOON PRESSURES, THE PHYSICIAN "RESPECTED THE VALUES." NO SECTIONS OF THE BALLOON REMAINED IN THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18042936 ↗
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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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