Advance Micro G26641Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002266411), received between Jun 12, 2018 and Dec 9, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Separation” (2 reports).
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
- Material Separation2
- Device Operates Differently Than Expected1
- Difficult to Remove1
- Fluid/Blood Leak1
- Material Rupture1
- Stretched1
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2024Fluid/Blood Leak; Fluid/Blood Leak
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20884561 ↗MalfunctionApr 14, 2020Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9957087 ↗MalfunctionMar 1, 2019Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8382811 ↗MalfunctionJul 13, 2018Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture
DURING AN ANGIOPLASTY PROCEDURE TREATING A LESION IN THE DISTAL ANTERIOR TIBIAL ARTERY, THE BALLOON PORTION OF THE ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER RUPTURED LONGITUDINALLY AFTER INFLATION, AT "NO MORE THAN" 16 ATMOSPHERES (ATM). THE COMPLAINT DEVICE WAS REMOVED WITH SOME DIFFICULTY, REPORTEDLY CATCHING ON CALCIFIED PORTION OF THE PATIENT'S VASCULATURE. ANOTHER BALLOON CATHETER WAS INSERTED TO AID WITH REMOVAL. THE COMPLAINT DEVICE WAS COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 Known Impact Or Consequence To Patient
MAUDE report 7686886 ↗MalfunctionJun 12, 2018Stretched; Device Operates Differently Than Expected
THE COMPLAINANT REPORTED A CROSS-OVER PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) IN THE CRURAL VESSELS. ANOTHER MANUFACTURER'S WIRE GUIDE WAS STUCK INSIDE THE ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER DURING RECANALIZATION OF THE CRURAL VESSELS. IT WAS FURTHER NOTED THAT THE WIRE GUIDE REMAINED INSIDE THE BALLOON CATHETER, AND A PORTION OF THE CATHETER FELT STRETCHED. 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 7591460 ↗
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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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