Advance G52274Recalls & 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 10827002522746), received between Jan 19, 2017 and May 17, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (3 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 Rupture3
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 17, 2018Material Rupture; Material Rupture
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. REFER TO SECTION H10 FOR INVESTIGATION FINDINGS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7523364 ↗MalfunctionApr 12, 2017Material Rupture; Material Rupture
IT WAS REPORTED THAT AN ADVANCE 35 LOW PROFILE BALLOON CATHETER WAS BEING USED FOR PRE-DILATION OF AN IN-STENT OCCLUSION OF AN ILIAC ARTERY. THE BALLOON RUPTURED. IT IS UNKNOWN WHICH DIRECTION THE BALLOON RUPTURED. AN ATTEMPT WAS MADE TO USE A SECOND ADVANCE 35 LP LOW PROFILE BALLOON CATHETER, SEE MFR REPORT 1820334-2017-00705. THE SECOND CATHETER RUPTURED AS WELL. ANOTHER MANUFACTURER'S DEVICE WAS THEN USED TO PERFORM PRE-DILATION. AFTER ANOTHER MANUFACTURER'S STENT PLACEMENT DURING POST-DILATION THE VESSEL RUPTURED. ANOTHER MANUFACTURER'S STENT GRAFT WAS THEN PLACED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6486751 ↗MalfunctionJan 19, 2017Material Rupture; Material Rupture
NO ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6263642 ↗
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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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