Advance G50257Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002502571), received between Jun 11, 2018 and Jan 17, 2020 — classified as 1 injury, 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
- Material Separation1
- Sticking1
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 2020Material Rupture; Material Rupture
ADDITIONAL INFORMATION RECEIVED 12FEB2020. AS REPORTED, THE PATIENT PRESENTED WITH MILD VESSEL CALCIFICATION AND AN 80% OCCLUDED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE BALLOON WAS INFLATED WITH AN INFLATION DEVICE AND 50/50 VISIPAQUE TO HEPARINIZED SALINE DILUTED CONTRAST FOR APPROXIMATELY 10 SECONDS AND TO EIGHT ATMOSPHERES BEFORE RUPTURING. BLOOD WAS OBSERVED IN THE UNKNOWN INFLATION DEVICE AFTER THE BALLOON RUPTURED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9601976 ↗InjuryNov 16, 2018Material Rupture; Material Separation; Material Rupture; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Code Available
MAUDE report 8080916 ↗MalfunctionJun 11, 2018Sticking
IT WAS REPORTED THAT DURING THE STENOSIS REPAIR PROCEDURE, THE INFLATED BALLOON ACCORDIONED THE SHEATH AND GOT STUCK. THE USER HAD TO REMOVE EVERYTHING AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. IT WAS ALSO LATER NOTED THAT THE SHEATH HAD EXTREME DAMAGES AND THE BALLOON COULD NOT BE SEPARATED FROM IT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7587949 ↗
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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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