Advance Micro G26601Recalls & 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 10827002266015), received between Jun 5, 2018 and Jun 5, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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 Rupture1
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.
MalfunctionJun 5, 2018Material Rupture; Material Rupture
IT WAS REPORTED, DURING A LOWER EXTREMITY ANGIOPLASTY THE ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER RUPTURED IN THE PATIENT'S CALCIFIED VESSEL. THERE WAS NO VESSEL ANGULATION. THE COMPLAINT DEVICE WAS REMOVED IN ITS ENTIRETY FROM THE PATIENT'S ANATOMY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER BALLOON CATHETER. ALTHOUGH REQUESTED, THE COMPLAINANT DID NOT KNOW IF THE COMPLAINT DEVICE RUPTURED LONGITUDINALLY OR CIRCUMFERENTIALLY. ADDITIONALLY, THE INFLATION PRESSURE AT THE TIME OF THE EVENT WAS UNKNOWN. 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 7570616 ↗
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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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