Advance G30844Recalls & reported problems
Cook Incorporated · Advance, 18LP Low Profile PTA Balloon Dilatation Catheter · Class 2
All models of Advance (206)
Data updated Oct 18, 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 10827002308449), received between Oct 16, 2017 and Oct 16, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
- Material Separation1
Patient problems
- Device Embedded In Tissue or Plaque1
- 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.
InjuryOct 16, 2017Break; Material Separation; Break; Material Separation
AN ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER WAS USED IN A PTA/STENT PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY WITH SEVERE CALCIFICATION. IT WAS REPORTED THAT THE BALLOON WAS BEING REMOVED OVER THE WIRE WHEN THE SHAFT BROKE AT THE "RX EXIT PORT". THE BROKEN PORTION OF THE BALLOON WAS REMOVED USING A SNARE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Device Embedded In Tissue or Plaque; No Code Available
MAUDE report 6953574 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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