Advance G30937Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002309378), received between Nov 2, 2017 and Mar 30, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (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 Puncture/Hole1
- Material Rupture1
Patient problems
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2022Material Puncture/Hole; Material Puncture/Hole
AS REPORTED, DURING AN UNSPECIFIED PROCEDURE USING A ADVANCE 18 LP LOW PROFILE BALLOON CATHETER, THERE WAS A HOLE NOTED IN THE BALLOON MATERIAL OF THE DEVICE. ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13952830 ↗MalfunctionNov 2, 2017Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY OF THE LOWER EXTREMITY FOR A POPLITEAL LESION, THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE BALLOON WAS INFLATED AT NOMINAL PRESSURE, AND THE PATIENT WAS REPORTED TO HAVE VESSEL CALCIFICATION. TWO BALLOON CATHETERS RUPTURED DURING THE PROCEDURE, REFER TO MDR 1820334-2017-03678 FOR ADDITIONAL REPORT. THE ANGIOPLASTY WAS ABLE TO BE SUCCESSFULLY COMPLETED WITH ANOTHER COOK MEDICAL BALLOON CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6996844 ↗
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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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