Advance G18798Recalls & 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
- 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 10827002187983), received between Nov 17, 2017 and Nov 17, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
- Material Rupture1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2017Deflation Problem; Material Rupture; Deflation Problem; Material Rupture
IT WAS REPORTED THAT DURING AN ANGIOPLASTY, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER DEFLATED, COULD NOT HOLD PRESSURE, AND RUPTURED AT 10 ATMOSPHERE (ATM). DURING INSPECTION OF THE BALLOON AT THE END OF THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS NOT PIERCED BUT A LEAK WAS PRESENT AT THE LEVEL OF THE SUPPORT CATHETER. THE BALLOON WAS ABLE TO BE INFLATED UP TO 8 ATM; HOWEVER, A CONSTANT PRESSURE OF 10 ATM WAS NOT ABLE TO BE APPLIED FROM THIRTY (30) SECONDS TO ONE (1) MINUTE AS THE BALLOON WAS DEFLATING. THE PATIENT HAD STENOSIS PRIOR TO THE ANGIOPLASTY PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7042808 ↗
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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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