Advance G30961Recalls & reported problems
Cook Incorporated · Advance, 18LP Low Profile PTA Balloon Dilatation Catheter · Class 2
Data updated Oct 13, 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 10827002309613), received between Nov 26, 2018 and Nov 26, 2018 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Rupture1
- Material Separation1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2018Material Rupture; Material Separation; Material Rupture; Material Separation
IT WAS REPORTED THAT DURING A SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED AND SEPARATED. THE BALLOON DEVICE WAS INFLATED IN THE DISTAL SFA USING ISOVIEW 50/50 MIXTURE. THE DEVICE WAS INFLATED TO NOMINAL PRESSURE INSIDE ANOTHER MANUFACTURER'S STENT WHEN IT CIRCUMFERENTIALLY RUPTURED. REPORTED PRE-EXISTING CONDITIONS INCLUDE PERIPHERAL ARTERY DISEASE, DIABETES, AND HYPERTENSION. THERE HAS BEEN NO REPORT OF ANGULATION OR CALCIFICATION REGARDING THE PATIENT ANATOMY. UPON REMOVAL OF THE BALLOON DEVICE, IT WAS OBSERVED THAT A PORTION OF THE BALLOON MATERIAL SEPARATED AND WAS SNARED USING ANOTHER MANUFACTURER'S DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 8103217 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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