Advance Micro G26653Recalls & 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 10827002266534), received between Jun 14, 2018 and Jun 14, 2018 — classified as 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Break1
- Sticking1
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 14, 2018Break; Sticking
THE COMPLAINANT REPORTED THAT THE WIRE WAS STUCK IN THE LUMEN OF THE ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER DURING TREATMENT IN AN ANTERIOR TIBIAL ARTERY. THIS PRODUCT PROBLEM OCCURRED AFTER THE BALLOON CATHETER WAS DILATED DURING THE PROCEDURE, AND IT WAS FURTHER NOTED THAT THE CATHETER HAD A BROKEN COIL IN THE BRAIDING. THE WIRE AND THE BALLOON CATHETER HAD TO BE REMOVED TOGETHER. THE DOCTOR USED A NEW WIRE AND BALLOON CATHETER FOR THE PROCEDURE, AND THE PROCEDURE WAS PROLONGED BY APPROXIMATELY 55 MINUTES. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7601713 ↗
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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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