Advance G52247Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002522470), received between Apr 18, 2019 and Jul 26, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 26, 2023Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING AN UNSPECIFIED ANGIOPLASTY PROCEDURE, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON LEAKED. THE BALLOON WAS ADVANCED ALONG THE WIRE GUIDE INTO THE LEFT FEMORAL/POPLITEAL ARTERIES TO TREAT LESIONS WITHIN THE DISTAL SUPERFICIAL FEMORAL ARTERY AS WELL AS BELOW THE KNEE. A 70% OCCLUDED LESION WAS REPORTED IN "SECTION P2". THE BALLOON WAS UNABLE TO BE INFLATED WITH AN UNSPECIFIED PRESSURE PUMP, SO THE PHYSICIAN APPLIED MORE PRESSURE, AT WHICH POINT CONTRAST LEAKED FROM THE BALLOON. BLOOD WAS NOT NOTED WITHIN THE INFLATION DEVICE; HOWEVER, A VIDEO PROVIDED BY THE CUSTOMER SHOWS CONTRAST LEAKING DISTALLY FROM THE BALLOON. ANOTHER DEVICE WAS USED TO COMPLETE THE 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. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17398375 ↗MalfunctionApr 18, 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 8529170 ↗
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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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