Advance G52263Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002522630), received between Mar 8, 2019 and Dec 3, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
- Inflation Problem1
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE DEVICE WAS FIRST USED IN SUCCESSFUL ANGIOPLASTY OF THE LEFT PROXIMAL-MID SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS REMOVED, AND A STENT WAS PLACED IN THE LEFT LEG. THE DEVICE WAS THEN PLACED IN THE RIGHT EXTERNAL ILIAC, WHICH WAS SIGNIFICANTLY CALCIFIED, AND RUPTURED. ADDITIONAL EVENT AND PATIENT OUTCOME INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12923204 ↗MalfunctionMay 9, 2019Inflation Problem; Inflation Problem
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 8595530 ↗MalfunctionMar 8, 2019Deflation Problem; Deflation Problem
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 8404053 ↗
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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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