Advance G30940Recalls & 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 10827002309408), received between Sep 3, 2019 and Apr 1, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 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 Rupture2
- Break1
- Material Separation1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2022Break; Material Rupture; Material Separation; Break; Material Rupture; Material Separation
AS REPORTED, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED DURING AN UNSPECIFIED PROCEDURE WHILE INSIDE A SHEATH. ADDITIONAL EVENT AND PATIENT OUTCOME INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13977716 ↗MalfunctionSep 3, 2019Material Rupture; Material Rupture
ADDITIONAL INFORMATION WAS RECEIVED NOTING THAT THE DEVICE WAS NOT FRACTURED, ONLY KINKED. THOUGH THIS KINK OCCURRED DURING THE REMOVAL OF THE DEVICE, NO RESISTANCE WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8956881 ↗
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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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