Advance Serenity™ 18 SER18-135-60-150Recalls & reported problems
Creagh Medical Limited · 018 Advance Serenity 6x150, 135cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05391525787176), received between Nov 6, 2023 and Dec 3, 2024 — classified as 2 malfunctions.
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
- Loss of or Failure to Bond1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
THE BALLOON CATHETER WAS USED A LOWER LEG ANGIOGRAM OF THE SUPERFICIAL FEMORAL ARTERY (SFA). FOLLOWING CROSSING THE LESION AND BALLOONING, THE BALLOON DETACHED FROM THE CATHETER AND HAD TO BE RETRIEVED VIA A SNARE. THE BALLOON WAS FULLY REMOVED FROM THE PATIENT WITHOUT HARM. THE BALLOON WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION INDICATED THE BALLOON WAS PREPPED PER IFU AND THERE WAS NO INDICATION OF DEVICE DAMAGE. THE SITE CONFIRMED NEGATIVE PRESSURE WAS HELD DURING LOADING AND MOVEMENT TO THE TARGET LESION. THERE WAS NO INDICATION OF NEGATIVE PRESSURE LOSS DURING LOADING. THE TARGET VESSEL HAD MODERATE CALCIFICATION WITH A LESION LENGTH OF APPROXIMATELY 60-80 MM. THE DEGREE OF STENOSIS WAS NOTED TO BE MODERATE. THE REPORTED ISSUE OCCURRED AFTER THE INITIAL INFLATION. THE PROCEDURE WAS CONSIDERED SUCCESSFUL. THE LENGTH OF PROCEDURE DELAY WAS REPORTED TO BE 10-15 MINUTES. THE PATIENT WAS REPORTED TO BE STABLE WITHOUT ISSUE.
Patient problems: Foreign Body In Patient
MAUDE report 20839621 ↗MalfunctionNov 6, 2023Fracture; Fracture
DURING A LOWER LEG ANGIOPLASTY, THE BALLOON BURST BEFORE THE RATED BURST PRESSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF A COMPETITOR 'S DEVICE. THE DEVICE WAS DISPOSED OF BY THE CUSTOMER. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18076321 ↗
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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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