Advance Micro G26710Recalls & 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 10827002267104), received between Jan 15, 2020 and Jan 15, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
- Material Separation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2020Leak/Splash; Material Separation; Leak/Splash; Material Separation
AS REPORTED, DURING AN ARTERIOGRAM AND RIGHT LOWER LIMB ANGIOPLASTY PROCEDURE INVOLVING A PATIENT WITH PERIPHERAL OBSTRUCTIVE ARTERIAL DISEASE AND A HISTORY OF LEFT LOWER LIMB ANGIOPLASTY, A COOK ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER LEAKED AND SEPARATED. DURING ANGIOPLASTY, A SMALL LEAK WAS NOTED IN THE PROXIMAL PART OF THE CATHETER AND THE BALLOON WOULD NOT INFLATE. AS THE CATHETER WAS REMOVED, IT SEPARATED AT THE LOCATION OF THE LEAK, JUST BELOW THE HUB. THE DEVICE WAS REMOVED WITH DIFFICULTY OVER AN UNKNOWN WIRE GUIDE. 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 Consequences Or Impact To Patient
MAUDE report 9590294 ↗
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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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