Advance Micro G26098Recalls & 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 10827002260983), received between Sep 30, 2024 and Sep 30, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionSep 30, 2024Break; Break
AS REPORTED, DURING A PROCEDURE INVOLVING ANGIOPLASTY OF THE ANTERIOR TIBIAL ARTERY, AN ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER SEPARATED. ACCESS WAS OBTAINED IN THE PEDAL ARTERY, USING A COOK PEDAL ACCESS SET. SINGLE FEMORAL ACCESS WAS ALSO OBTAINED. THE BALLOON CATHETER TRACKED NORMALLY THROUGH THE LESION, AND THE BALLOON WAS INFLATED AND DEFLATED, COMPLETING THE PROCEDURE. WHEN THE USER REPORTEDLY ¿PINCHED¿ THE SHAFT OF THE DEVICE BETWEEN HIS FINGERS TO REMOVE IT, THE SHAFT BROKE WHERE IT WAS ¿PINCHED¿. THE USER PULLED SOME OF THE SHAFT OUT AND READJUSTED HIS FINGERS; HOWEVER, THE SHAFT BROKE AGAIN. REPORTEDLY, THIS HAPPENED SEVERAL TIMES BEFORE THE TIP SEPARATED IN THE PATIENT. PER THE REPORTER, RESISTANCE WAS NOT ENCOUNTERED UPON REMOVAL OF THE CATHETER UNTIL THE SHAFT SEPARATED AND CONTINUED TO BREAK. THE SEPARATED PORTION OF THE CATHETER REMAINED ON THE WIRE GUIDE; THEREFORE, THE USER EXTERNALIZED THE WIRE GUIDE FROM A FEMORAL APPROACH, AND A COOK CXI CATHETER WAS ADVANCED FROM THE FEMORAL SITE AND USED TO PUSH THE TIP OF THE DEVICE INTO THE PEDAL ACCESS SHEATH. THE SEPARATED PORTION OF THE COMPLAINT DEVICE WAS SUCCESSFULLY REMOVED. THE HOSPITAL LENGTH OF STA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20340436 ↗
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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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