Advance Serenity™ 18 SER18-150-40-220Recalls & 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 05391525784366), received between Jun 26, 2024 and Jun 26, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Deflate” (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
- Failure to Deflate1
- Fracture1
Patient problems
- Ischemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2024Fracture; Failure to Deflate; Fracture; Failure to Deflate
ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR INDICATED THE REPORTED ISSUE OCCURRED DURING AN ANGIOPLASTY PROCEDURE IN WHICH A VENOGRAM AND ILIAC VEIN STENTING WERE CONDUCTED. THE BALLOON CATHETER WAS PREPPED PER IFU. THERE WAS NO INDICATION OF DEVICE DAMAGE DURING PREPARATION. IT WAS NOTED NEGATIVE PRESSURE WAS NOT HELD ON THE BALLOON WHILE LOADING AND ADVANCEMENT TO THE TARGET LESION. THE SITE DENIED TORQUING/TWISTING THE DEVICE DURING LOADING AND ADVANCEMENT. 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 INABILITY TO DEFLATE THE BALLOON CATHETER 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. A HIGH-P
Patient problems: Ischemia
MAUDE report 19619687 ↗
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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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