Advance Micro G26195Recalls & reported problems
Cook Incorporated · Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter · Class 2
All models of Advance Micro (25)
Data updated Oct 16, 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 10827002261959), received between Sep 17, 2018 and Sep 17, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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 16, 2026.
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2018Material Separation; Material Separation
IT WAS REPORTED, THE TIP OF AN ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON LOOSENED AND SEPARATED FROM THE CATHETER AFTER PREDILATION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. THE COMPLAINT DEVICE WAS BEING USED TO TREAT AN OCCLUSION IN THE HEAVILY CALCIFIED SFA WHEN IT BECAME LODGED. AS THE PHYSICIAN WAS TRYING TO REMOVE THE COMPLAINT DEVICE, IT WAS REPORTED TO BE "TOO TIGHT". THE GUIDE WIRE ALSO CAME OUT WITH THE BALLOON CATHETER. IT WAS NOTED THE TIP OF THE BALLOON WAS ON THE GUIDEWIRE. THE ADVANCE MICRO¿ 14 ULTRA LOW-PROFILE PTA BALLOON WAS BEING USED THROUGH A 6FRENCH SHEATH AND, DURING THE REMOVAL WAS RETRIEVED WITH A CLOCKWISE ROTATION. THE PREDILATION OF THE VESSEL HAD BEEN COMPLETED AT THE TIME OF THE EVENT; THEREFORE, THE PROCEDURE WAS ABLE TO BE COMPLETED AS USUAL AND THE PATIENT HAD A GOOD OUTCOME. NO PATIENT ADVERSE EFFECTS HAVE BEEN REPORTED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7881228 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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