Advance G50258Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002502588), received between Mar 25, 2022 and Mar 25, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 25, 2022Material Rupture; Material Rupture
AS REPORTED, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED UPON INFLATION TO FOUR ATMOSPHERES. THE BALLOON WAS USED TO OCCLUDE FLOW AS THROMBIN WAS INJECTED INTO A PSEUDOANEURYSM. THROMBIN LEAKED INTO THE FISTULA AFTER THE BALLOON RUPTURED. AN UNSPECIFIED COOK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. THERE HAS BEEN NO REPORT OF ANY ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13904046 ↗
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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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