Advance Micro G26678Recalls & 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 10827002266787), received between Nov 22, 2021 and Nov 22, 2021 — 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 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.
MalfunctionNov 22, 2021Material Rupture; Material Rupture
ASA REPORTED, DURING A PERIPHERAL ARTERY DISEASE PROCEDURE AN ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER WAS BEING USED, AND THE BALLOON RUPTURED. THE BALLOON WAS INFLATED ONCE AND UPON THE SECOND INFLATION THE BALLOON RUPTURE OCCURRED. THE DEVICE WAS USED WITH A VIPER 014 WIRE, AND A 6FR 12CM ACCESS SHEATH WAS UTILIZED. A COOK INFLATION DEVICE WAS ALSO USED. THE BALLOON WAS INFLATED TO 8ATM. JUST THE BALLOON WAS REMOVED FOLLOWING THE MALFUNCTION. THE PATIENT DID HAVE CALCIFIED ANATOMY. THE LESION WAS LOCATED JUST BELOW THE TIBIAL TRUNK OF THE PERONEAL ARTERY, AND THE VESSEL WAS OCCLUDED LESS THAN 10 PERCENT. THE BALLOON WAS NO INFLATED INSIDE OF A STENT PRIOR TO RUPTURE. A SAME TYPE DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12856134 ↗
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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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