Advance Serenity™ 18 SER18-135-50-80Recalls & reported problems
Creagh Medical Limited · 018 Advance Serenity 5x80, 135cm · 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 05391525787060), received between Sep 25, 2023 and Sep 25, 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.
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.
MalfunctionSep 25, 2023Fracture; Fracture
THE DEVICE WAS BEING USED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) POST AN ATHERECTOMY PROCEDURE. THE BALLOON CATHETER RUPTURED WHEN INFLATED TO 10ATM. NO RESISTANCE WAS EXPERIENCED DURING BALLOON PLACEMENT. THE VESSEL WAS REPORTED TO BE HIGHLY CALCIFIED WITH A LESION LENGTH OF APPROXIMATELY 80MM AND STENOSIS OF A DEGREE OF 80%. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER BALLOON. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES. THERE WAS NO IMPACT TO PATIENT OUTCOME AND NO PATIENT HARM. THE REPORTED ISSUE DID NOT RESULT IN A PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17813959 ↗
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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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