Advance G52275Recalls & reported problems
Cook Incorporated · Advance, 35LP Low Profile PTA Balloon Dilatation Catheter · Class 2
All models of Advance (206)
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 10827002522753), received between Jul 14, 2017 and Jul 14, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
Patient problems
- No Known Impact Or Consequence 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 14, 2017Difficult to Remove
THE INFORMATION RECEIVED INDICATED THAT AFTER THE ANGIOPLASTY THE SURGEON ENCOUNTERED DIFFICULTY REMOVING THE BALLOON. THE TARGET LESION WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY, LESION CHARACTERISTICS WERE NOT PROVIDED. AFTER ANGIOPLASTY THE SURGEON HAD DIFFICULTY REMOVING THE BALLOON DESPITE DEFLATION AND NEGATIVE PRESSURE. ONCE THE BALLOON WAS REMOVED THE PHYSICIAN EXAMINED THE BALLOON AND NOTICED A "BULGE" ON THE DISTAL PORTION OF THE BALLOON. ACCORDING TO THE REPORTER A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT, NO ADDITIONAL PROCEDURES WERE REQUIRED AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THE ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6714766 ↗
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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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