Advance G52355Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002523552), received between Aug 3, 2017 and Aug 3, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Hole In Material” (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
- Hole In Material1
- Inflation Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2017Hole In Material; Inflation Problem; Hole In Material; Inflation Problem
IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS UNABLE TO INFLATE INSIDE THE PATIENT. THE BALLOON WAS REMOVED AND AN ATTEMPT WAS MADE TO INFLATE IT OUTSIDE THE PATIENT, BUT A PIN HOLE WAS FOUND IN THE BALLOON MATERIAL. ANOTHER ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS THEN USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT'S ANATOMY WAS NOT CALCIFIED OR TORTUOUS. IT WAS ALSO STATED THAT THERE WAS NO SCAR TISSUE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6765932 ↗
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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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