Advance G34320Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002343204), received between Aug 3, 2018 and Aug 3, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inflation Problem” (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
- Inflation Problem1
- Leak/Splash1
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.
MalfunctionAug 3, 2018Inflation Problem; Leak/Splash
THE FOLLOWING INFORMATION WAS REPORTED: DURING AN INTERVENTION ON THE LEFT FEMORAL ARTERY PROCEDURE, THE USER PLACED THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER IN ORDER TO DILATE THE ARTERY. THERE WAS AN ATTEMPT TO INFLATE THE BALLOON, BUT THE BALLOON WOULD NOT TAKE SHAPE AND THE USER COULD NOT ACHIEVE SIGNIFICANT ATMS (ATMOSPHERES). THE BALLOON WAS REMOVED AND THE USER ATTEMPTED TO BLOW IT UP ON THE TABLE TOP, BUT CONTRAST SPRAYED OUT OF THE SIDE OF THE BALLOON. THERE DID NOT SEEM TO BE A RUPTURE. THE PROCEDURE WAS COMPLETED WITH "GREAT RESULT" WITH ANOTHER BALLOON. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7747100 ↗
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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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