Advance Serenity™ 18 SER18-135-60-100Recalls & reported problems
Creagh Medical Limited · 018 Advance Serenity 6x100, 135cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05391525787152), received between Apr 4, 2025 and Oct 29, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Deflate” (2 reports).
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 Deflate2
- Difficult to Remove1
- Failure to Unfold or Unwrap1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2025Failure to Unfold or Unwrap; Failure to Deflate; Failure to Unfold or Unwrap; Failure to Deflate
THE BALLOON CATHETER WAS USED DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. THE BALLOON WAS PLACED IN TIGHT VENOUS STENOSIS IN THE SUBCLAVIAN. IT WAS REPORTED THE BALLOON WOULD NOT DEFLATE AFTER BEING OVERINFLATED TO 18 ATM. IT WAS NOTED THE RATED BURST PRESSURE (RBP) FOR THIS BALLOON MODEL IS 16 ATM. THE SITE REPORTEDLY USING "FULL CONTRAST." THE PHYSICIAN USED ULTRASOUND GUIDANCE TO PUNCTURE THE BALLOON WITH A NEEDLE. THE PHYSICIAN WAS ABLE TO FULLY REMOVE THE BALLOON WITHOUT ISSUE. THERE WAS NO REPORTED PROCEDURE DELAY OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23417260 ↗InjuryApr 4, 2025Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate
THE BALLOON CATHETER WAS USED DURING AN ANGIOPLASTY PROCEDURE. THE PHYSICIAN WAS UNABLE TO RETRACT THE BALLOON INTO THE PROCEDURAL SHEATH. THE REPORTED ISSUE RESULTED IN ADDITIONAL RADIATION EXPOSURE TO THE PATIENT AND THE USE OF ALTERNATIVE MEANS TO REMOVE THE BALLOON. THE BALLOON WAS ABLE TO BE REMOVED BY SNARING FROM A SECOND VASCULAR ACCESS SITE. THERE WAS NO FURTHER PATIENT IMPACT OR PROCEDURE DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21778495 ↗
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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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