Advance G30950Recalls & 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 10827002309507), received between Aug 15, 2019 and Aug 15, 2019 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Rupture1
Patient problems
- No Consequences Or Impact 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 15, 2019Material Rupture; Material Rupture
AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE OF THE RIGHT SUPERFICIAL FEMORAL ARTERY INVOLVING A (B)(6) YEAR-OLD MALE PATIENT, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED INSIDE THE PATIENT. A 6 FRENCH 45 CENTIMETER COOK ANSEL SHEATH WAS USED DURING THE PROCEDURE AS WELL AS AN UNKNOWN INFLATION DEVICE. THE BALLOON WAS INFLATED USING A 50 / 50 SOLUTION OF VISIOPAQUE CONTRAST TO SALINE TO 8 ATMOSPHERES WHEN THE DEVICE RUPTURED. IT IS UNKNOWN IF THE DEVICE WAS INFLATED SUCCESSFULLY PRIOR TO RUPTURE OR IF THE BALLOON WAS INSERTED, REMOVED, AND REINSERTED. THE DEVICE WAS REMOVED OVER A WIRE BY ITSELF. THE VESSELS WERE REPORTEDLY HIGHLY CALCIFIED; HOWEVER, ANGULATION AND TORTUOSITY WERE NOT REPORTED. IT IS UNKNOWN IF THE DEVICE RUPTURED CIRCUMFERENTIALLY OR LONGITUDINALLY. BLOOD WAS NOT OBSERVED IN THE INFLATION DEVICE, AND THE BALLOON WAS NOT INFLATED INSIDE A STENT PRIOR TO RUPTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. DURING THE SAME PROCEDURE, ANOTHER COOK ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS UNABLE TO CROSS THE LESION (THIS IS A NON-REPORTABLE EVENT). IN ADDITION, ANOTHER COOK ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED. THIS EVENT WILL B
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8898352 ↗
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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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