Advance G35528Recalls & reported problems
Cook Incorporated · Advance, 35LP Low Profile PTA Balloon Dilatation Catheter · Class 2
Data updated Oct 13, 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 10827002355283), received between Jul 12, 2017 and Jul 12, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
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.
MalfunctionJul 12, 2017Burst Container or Vessel
THE INFORMATION RECEIVED INDICATED THAT A BALLOON BURST DURING A PERCUTANEOUS ANGIOPLASTY PROCEDURE. THE LESION WAS IN THE SUPERFICIAL FEMORAL ARTERY, DESCRIBED AS HEAVILY CALCIFIED AND A CHRONIC TOTAL OCCLUSION. THE BALLOON WAS DELIVERED TO THE TARGET LESION AND UPON INITIAL INFLATION TO 1-2 ATMOSPHERES THAT BALLOON RUPTURED. A SECOND BALLOON WAS USED AND THE SAME THING HAPPENED. THE PHYSICIAN DECIDED TO END THE PROCEDURE AND SEND THE PATIENT FOR BYPASS SURGERY. MDR 1820334-2017-01885 CAPTURES ADVERSE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6706448 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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