Advance G50331Recalls & reported problems
Cook Incorporated · Advance, 14LP 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002503318), received between Dec 5, 2018 and Jun 9, 2022 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (4 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 Rupture4
- Break1
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2022Break; Break
AS REPORTED, DURING AN UNKNOWN PROCEDURE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER'S LUER LOCK "BROKE". THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14644397 ↗MalfunctionAug 27, 2020Material Rupture; Material Rupture
AS REPORTED, DURING AN UNKNOWN PROCEDURE A ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED LONGITUDINALLY WHILE BEING INFLATED IN THE ATA. THE APPROACH WAS GAINED FROM THE LEFT FA AND THE BALLOON WAS ADVANCED TO THE LEFT ATA THROUGH A 6FR SHEATH WHERE IT WAS INFLATED ONCE TO ABOUT 8 ATM WITH A 1:1 MIXTURE OF CONTRAST AND SALINE. THE ARTERY WAS NOT NOTED TO BE CALCIFIED. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PORTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THIS DID NOT RESULT IN PROLONGED HOSPITALIZATION OR ADDITIONAL PROCEDURES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10459579 ↗MalfunctionJan 3, 2020Material Rupture; Material Rupture
AS REPORTED, DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY INVOLVING A PATIENT WITH A HISTORY OF PERIPHERAL ARTERY DISEASE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED. ACCESS WAS OBTAINED IN THE LEFT FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO TREAT A STENOSED LESION WITHIN THE RIGHT SUPERFICIAL FEMORAL ARTERY. ANOTHER MANUFACTURER'S 0.014 INCH WIRE GUIDE PASSED THROUGH THE LESION, AND THE COMPLAINT DEVICE WAS THEN INFLATED; HOWEVER, THE DEVICE RUPTURED AT 16 ATMOSPHERES. THE BALLOON WAS REMOVED AND EXCHANGED FOR ANOTHER MANUFACTURER'S BALLOON TO COMPLETE THE PROCEDURE. 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 9544581 ↗MalfunctionApr 11, 2019Material Rupture; Material Rupture
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8503583 ↗MalfunctionDec 5, 2018Material Rupture; Material Rupture
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8134064 ↗
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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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