Advance Serenity™ 14 SER14-150-25-100Recalls & reported problems
Creagh Medical Limited · Advance Serenity 14 2.5mm x 10cm x 150cm · 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 05391525784830), received between Jul 18, 2022 and Jul 18, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inflation Problem” (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
- Inflation Problem1
- Material Rupture1
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.
MalfunctionJul 18, 2022Inflation Problem; Material Rupture; Inflation Problem; Material Rupture
PER REP - ON (B)(6) 2022 - THE BALLOON BURST (12 ATM) BEFORE THE RATED BURST LEVEL (16 ATM). NO PART SEPARATED IN THE PATIENT. THEY REMOVED THE BALLOON AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER DEVICE OF THE SAME TYPE (DIFFERENT SIZE). THE BALLOON WAS USED OVER A .014, 300 CM COOK HYDRO ST WIRE. TYPE OF PROCEDURE: TIBIAL ANGIOPLASTY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15041569 ↗
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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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