Advance G52327Recalls & reported problems
Cook Incorporated · Advance, 35LP Low Profile PTA Balloon Dilatation Catheter · Class 2
All models of Advance (206)
Data updated Oct 18, 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 10827002523279), received between Jul 26, 2017 and Jul 26, 2017 — 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 18, 2026.
Most reported problems
Device problems
- Break1
- Deflation Problem1
- Fluid/Blood Leak1
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.
MalfunctionJul 26, 2017Break; Deflation Problem; Fluid/Blood Leak
IT WAS REPORTED THAT DURING A SFA (SUPERFICIAL FEMORAL ARTERY)/POPLITEAL ANGIOPLASTY, TWO BALLOONS OF THE SAME LOT BROKE BEFORE NOMINAL PRESSURE AND DEFLATED SLOWLY WITH A CONTRAST LEAK. IT WAS NOTED THERE WAS A PINHOLE IN THE ONE OF THE BALLOONS. NO SECTION OF THE DEVICE(S) REMAINED INSIDE THE PATIENT AND NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6745276 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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