Advance G30944Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002309446), received between Jan 13, 2017 and Jan 27, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak2
- Material Rupture2
Patient problems
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2020Fluid/Blood Leak; Fluid/Blood Leak
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 9632654 ↗MalfunctionJan 24, 2019Fluid/Blood Leak; Fluid/Blood Leak
PLEASE SEE H10 FOR ADDITIONAL INFORMATION RECEIVED 01/25/2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8275357 ↗MalfunctionAug 10, 2017Material Rupture; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE INVOLVING A (B)(6) MALE, THE ADVANCE 18 LP BALLOON RUPTURED. IT WAS REMOVED FROM THE PATIENT, AND ANOTHER BALLOON WAS NOT NEEDED AS THIS WAS THE END OF THE PROCEDURE. 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 Known Impact Or Consequence To Patient
MAUDE report 6785894 ↗MalfunctionJan 13, 2017Material Rupture; Material Rupture
ADDITIONAL INFORMATION RECEIVED ON 01/23/2017 STATED THAT A 7 FRENCH SHEATH WAS UTILIZED. THE WIRE GUIDE WAS IN PLACE DURING INFLATION AND REMOVAL. THE LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. THERE WAS NO ANGULATION OR CALCIFICATION OF THE VESSEL. THERE IS NO INFORMATION PROVIDED THAT STATES WHETHER OR NOT THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS ALLOWED TO RETURN TO AMBIENT PRESSURE ONCE THE DEVICE WAS DEFLATED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6248965 ↗
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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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