Advance Micro G26095Recalls & reported problems
Cook Incorporated · Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002260952), received between May 1, 2024 and May 1, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Material Deformation1
- Material Separation1
Patient problems
- 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.
MalfunctionMay 1, 2024Difficult to Remove; Material Separation; Material Deformation; Difficult to Remove; Material Separation; Material Deformation
ADDITIONAL INFORMATION WAS RECEIVED 16MAY2024. IT IS UNKNOWN WHAT WIRE WAS USED. THE BALLOON CATHETER'S WIRE LUMEN WAS FLUSHED WITH HEPARINIZED SALINE. THE USER DID NOT ATTEMPT TO INFLATE THE BALLOON PRIOR TO ADVANCEMENT OVER THE WIRE. THE BALLOON CATHETER DID NOT ENTER THE SHEATH AND IT WAS NOT INSERTED INTO THE PATIENT. IT IS UNKNOWN FOR CERTAIN IF THE BALLOON CATHETER WAS ADVANCED USING A COUNTERCLOCKWISE ROTATION. THE USER WAS UNABLE TO REMOVE THE BALLOON CATHETER FROM THE WIRE AFTER THE WIRE WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19220935 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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