Advance G52264Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002522647), received between Oct 17, 2018 and May 16, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture2
- Break1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 16, 2022Break; Material Rupture; Material Separation; Break; Material Rupture; Material Separation
AS REPORTED, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETERS RUPTURED CIRCUMFERENTIALLY AND TORE IN HALF. THE HIGHLY CALCIFIED LESION WAS AT THE COMMON ILIAC ARTERY AND STENTED WITH AN UNKNOWN MANUFACTURER'S STENT. THE BALLOON WAS INSERTED THROUGH A 6FR COOK RABBE SHEATH WITH ANOTHER MANUFACTURE'S GUIDE WIRE, INFLATED TO 14 ATMOSPHERES, AND SUBSEQUENTLY RUPTURED AND SEPARATED. HEMOSTATS WERE USED TO REMOVED THE SEPARATED PORTIONS OF THE DEVICE, HOWEVER, THE BALLOON MARKER WAS UNABLE TO BE REMOVED, REMAINING IN THE PATIENT'S SOFT TISSUE. BLOOD WAS NOTED IN THE INFLATION DEVICE AND THE BALLOON WAS INFLATED INSIDE A STENT PRIOR TO THE RUPTURE. A SECOND ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED DURING THE SAME PROCEDURE AND WILL BE REPORTED UNDER COOK REFERENCE # (B)(4). THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 14411010 ↗MalfunctionOct 17, 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 Known Impact Or Consequence To Patient
MAUDE report 7976607 ↗
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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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