Advance G30901Recalls & reported problems
Cook Incorporated · Advance, 18LP 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002309019), received between Apr 20, 2022 and Apr 20, 2022 — classified as 1 injury.
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
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 20, 2022Material Rupture; Material Separation; Material Rupture; Material Separation
AS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE POPLITEAL ARTERY, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED AND SEPARATED. AFTER THE BALLOON RUPTURED, IT WAS UNABLE TO BE REMOVED FROM AN UNKNOWN INTRODUCER AND SUBSEQUENTLY SEPARATED, LEAVING HALF OF THE BALLOON OVER AN UNKNOWN WIRE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A BARE METAL STENT WAS PLACED IN THE SFA TO HOLD THE FRAGMENT IN PLACE AND PREVENT MIGRATION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 14164086 ↗
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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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