Advance Serenity™ 14 SER14-150-20-220Recalls & reported problems
Creagh Medical Limited · Advance Serenity 14 2mm x 22cm x 150cm · 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 05391525784786), received between Jan 13, 2022 and Jan 13, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Rupture1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- 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.
InjuryJan 13, 2022Break; Material Rupture; Material Separation; Break; Material Rupture; Material Separation
DURING INTERVENTION PROCEDURE, CATHETER AND SHEATH ARE POSITIONED UP, THE GUIDEWIRE IS INSERTED FROM GROIN AND PEDAL ACCESS. DUE TO LONGER WIRE LENGTH AND BALLOON LENGTH KELLY CLAMP WAS USED. THE BALLOON WAS INFLATED TWICE AND THE INFLATION WORKED FINE. BUT WHILE REMOVING THE BALLOON, IT WAS SHEARED IN TO MULTIPLE SEGMENTS. THE PATIENT WAS NOT ABLE TO BE TREATED FOR THE OBSTRUCTIONS AND REQUIRED A HOSPITAL STAY AFTER THE EXTENDED PROCEDURE NECESSARY TO REMOVE THE BALLOON FRAGMENTS. NO SERIOUS HARM CAME TO THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 13254339 ↗
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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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