Advance Serenity™ 18 SER18-150-30-80Recalls & reported problems
Creagh Medical Limited · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05391525784168), received between Aug 31, 2024 and Aug 31, 2024 — classified as 1 injury.
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
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2024Loss of or Failure to Bond; Fracture; Loss of or Failure to Bond; Fracture
THE BALLOON CATHETER WAS USED DURING AN ANGIOPLASTY PROCEDURE IN WHICH A VENOGRAM AND ILIAC VEIN STENTING WERE CONDUCTED. DURING THE PROCEDURE THE BALLOON RUPTURED AND SHEARED OFF INSIDE THE PATIENT. THE PATIENT HAD A PREVIOUSLY PLACED STENT IN THE ILIAC VEIN EXTENDING INTO THE INFERIOR VENA CAVA (IVC). THE DISTAL END OF THE SENT (IN THE IVC) WAS OCCLUDED AND DIFFICULT TO CROSS WITH THE GUIDEWIRE AND CATHETER. ONCE CROSSED, THE BALLOON CATHETER WAS ADVANCED OVER THE WIRE. THE TARGET VESSEL WAS REPORTED TO BE "VERY TIGHT" WITH A LESION LENGTH OF APPROXIMATELY 5CM. THE BALLOON RUPTURE OCCURRED APPROXIMATELY 10-15 MINUTES INTO THE PROCEDURE. THE BALLOON WAS ONLY USED FOR THE INITIAL INFLATION IN WHICH THE NOMINAL PRESSURE (8ATM) WAS NOT REACHED. THE TYPE OF INFLATION DEVICE USED WAS NOT RECORDED. THE BALLOON CATHETER SEPARATED FROM THE SHAFT DURING REMOVAL AND A SNARE WAS REQUIRED. THE BALLOON FRAGMENT WAS LODGED AT THE DISTAL END OF A WALL STENT LOCATED IN THE INFERIOR VENA CAVA (IVC). A LOOP SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE SEGMENT. A HIGH PRESSURE BALLOON WAS ADVANCED OVER THE GUIDEWIRE, HOWEVER, THE SHAFT LENGTH WAS NOT LONG ENOUGH TO REACH THE LESION. A COMPETITOR BALL
Patient problems: Foreign Body In Patient
MAUDE report 20114820 ↗
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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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