Advance Micro G26677Recalls & 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 10827002266770), received between Jun 6, 2019 and Jun 6, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Perforation” (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 Perforation1
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.
MalfunctionJun 6, 2019Material Perforation; Material Perforation
ADDITIONAL INFORMATION WAS RECEIVED ON 11JUN2019 NOTING THAT THE COOK SHEATH WAS USED IN THIS PROCEDURE ALONG WITH AN UNKNOWN "INSUFFLATOR". THE DEVICE WAS INFLATED ONE TIME IN THE ANTERIOR TIBIAL ARTERY FOR 30 SECONDS, BUT WOULD NOT INFLATE OVER 2 ATMOSPHERES OF PRESSURE. A ONE PART HENETIX CONTRAST WAS USED WITH A TWO PART SALINE SOLUTION TO INFLATE THE BALLOON. WHEN REMOVING THE BALLOON OUT BY ITSELF, A PERFORATION WAS NOTED AT THE DISTAL END OF THE BALLOON. REPORTEDLY, THERE WAS NO ANGULATION, TORTUOSITY, OR CALCIFICATION. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO BLOOD NOTED IN THE INFLATION DEVICE AND THE BALLOON WAS NOT INFLATED INSIDE THE STENT PRIOR TO RUPTURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8677228 ↗
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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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