Advance G50253Recalls & 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 10827002502533), received between Jun 12, 2018 and Jun 12, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Kinked” (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
- Kinked1
- Occlusion Within Device1
- Sticking1
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.
MalfunctionJun 12, 2018Kinked; Occlusion Within Device; Sticking
IT WAS REPORTED THAT THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS INFLATED TO 12 ATM (ATMOSPHERES) INSIDE THE PATIENT AFTER USING A CROSSOVER APPROACH, BUT WHEN THE BALLOON WAS DEFLATED AND REMOVAL WAS ATTEMPTED, THE WIRE KINKED AND THE TWO COMPONENTS BECAME STUCK TOGETHER. IT WAS ALSO LATER NOTED THAT THE CATHETER WAS OCCLUDED. THE WIRE AND BALLOON CATHETER HAD TO BE REMOVED TOGETHER, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7592429 ↗
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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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