Advance G34375Recalls & reported problems
Cook Incorporated · Advance, 35LP 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 10827002343754), received between Jan 12, 2017 and Jul 16, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Material Rupture1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2019Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION WAS RECEIVED ON 16JUL2019 NOTING THAT THE TARGET LESION WAS THE POSTERIOR TIBIAL ARTERY. ADDITIONALLY, THERE WAS NO BLOOD NOTED IN THE INFLATION DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8796727 ↗MalfunctionJan 12, 2017Material Rupture; Material Rupture
IT WAS REPORTED AN INFLATION DEVICE, LOW PROFILE BALLOON CATHETER, POPPED DURING INFLATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED AT THE TIME OF THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6245767 ↗
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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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