Advance G34318Recalls & 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
- 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 10827002343181), received between Nov 27, 2018 and Nov 27, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture1
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.
MalfunctionNov 27, 2018Material Rupture; Material Rupture
IT WAS REPORTED, A (B)(6) FEMALE WAS UNDERGOING AN ANGIOPLASTY OF THE HIGHLY CALCIFIED, LEFT DISTAL POPLITEAL ARTERY WHEN THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED UPON THE INITIAL INFLATION. ACCORDING TO THE REPORTER, THE COMPLAINT DEVICE WAS INFLATED WITH A MIXTURE OF CONTRAST AND SALINE (RATIO UNKNOWN) VIA ANOTHER MANUFACTURER'S INFLATION DEVICE TO 14 ATMOSPHERES (ATM) WHEN THE RUPTURE OCCURRED. THE VESSEL WAS NOT ANGULATED. ANOTHER MANUFACTURER'S .014 INCH 300CM GUIDEWIRE AND A 5FRENCH (FR) 55CM ANSEL SHEATH WERE IN USE AT THE TIME. AFTER THE RUPTURE, THE COMPLAINT DEVICE WAS REMOVED IN ITS ENTIRETY WITHOUT THE SHEATH IN PLACE. THE PROCEDURE WAS SUCCESSFULLY ACCOMPLISHED WITHOUT ANY PATIENT ADVERSE EFFECT. NO ADDITIONAL PROCEDURES WERE REQUIRED AS A RESULT OF THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8106268 ↗
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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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