Advance G50242Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002502427), received between Apr 20, 2021 and Apr 20, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (3 reports).
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
- Material Rupture3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2021Material Rupture; Material Rupture
ADDITIONAL INFORMATION WAS RECEIVED 28APR2021. THE COMPLAINT DEVICE "PUNCTURED" RATHER THAN "SPLIT". THE BALLOON WAS NOT INFLATED WITHIN A STENT. BLOOD WAS NOTED IN THE INFLATION DEVICE UPON RUPTURE. THE PATIENT HAD SEVERE IRREGULAR CALCIFIC ATHEROSCLEROTIC DISEASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11694524 ↗MalfunctionApr 20, 2021Material Rupture; Material Rupture
ADDITIONAL INFORMATION WAS RECEIVED 28APR2021. THE COMPLAINT DEVICE "PUNCTURED" RATHER THAN "SPLIT". THE BALLOON WAS NOT INFLATED WITHIN A STENT. BLOOD WAS NOTED IN THE INFLATION DEVICE UPON RUPTURE. THE PATIENT HAD SEVERE IRREGULAR CALCIFIC ATHEROSCLEROTIC DISEASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11694336 ↗MalfunctionApr 20, 2021Material Rupture; Material Rupture
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11694222 ↗
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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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