Advance G50334Recalls & reported problems
Cook Incorporated · Advance, 14LP 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002503349), received between Jun 13, 2018 and Feb 12, 2020 — classified as 4 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 16, 2026.
Most reported problems
Device problems
- Material Rupture3
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2020Material Rupture; Material Rupture
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9699737 ↗MalfunctionMar 27, 2019Material Rupture; Material Rupture
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8457461 ↗MalfunctionJun 29, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, DURING A HEMODIALYSIS FISTULA ACCESS PROCEDURE, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER LEAKED CONTRAST IN THE PATIENT'S ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE COMPLAINT DEVICE ALONG THE WIRE GUIDE TO THE LESION LOCATED IN THE AREA OF THE CEPHALIC AND MEDIAN CUBITAL VEIN. THE COMPLAINT DEVICE WAS INFLATED USING CONTRAST MEDIUM AND NOTED THE CONTRAST LEAKING FROM THE BALLOON. THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS ENTIRELY REMOVED FROM THE PATIENT'S ANATOMY AND FOUND TO HAVE A "BROKEN" BALLOON. THE PHYSICIAN WAS ABLE TO USE ANOTHER ADVANCE 14 LP LOW PROFILE BALLOON CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECTS TO THE PATIENT. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7649960 ↗MalfunctionJun 13, 2018Material Rupture
IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE LOW PROFILE BALLOON CATHETER WAS USED, THE BALLOON RUPTURED. THERE WERE NO PATIENT INJURIES OR ADDITIONAL PROCEDURES REPORTED AND ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7595793 ↗
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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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