Advance G30909Recalls & 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
- 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 10827002309095), received between Aug 3, 2018 and Apr 1, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Material Rupture1
Patient problems
- Calcium Deposits/Calcification1
- No Clinical Signs, Symptoms or Conditions1
- Occlusion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2024Material Rupture; Material Rupture
AS REPORTED, DURING AN UNKNOWN PROCEDURE, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE FROM THE SAME LOT. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 19015554 ↗MalfunctionAug 3, 2018Insufficient Device Problem Information
THE COMPLAINANT REPORTED THAT THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED ACROSS A CALCIFIED LESION AND INFLATED TO 8 ATM (ATMOSPHERES) WITHOUT ANY PROBLEMS. AN ANGIOGRAM DISPLAYED OCCLUSION OF THE LEFT SFA (SUPERFICIAL FEMORAL ARTERY) AND POPLITEAL VESSEL. THE BALLOON WAS THEN PULLED BACK AND INFLATED FOR A SECOND TIME TO 8 ATM (ATMOSPHERES) WHEN THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED "OTW" AND WAS INTACT UPON REMOVAL. THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.
Patient problems: Calcium Deposits/Calcification; Occlusion
MAUDE report 7747468 ↗
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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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