Advance G50217Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002502175), received between Sep 29, 2016 and Sep 29, 2016 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2016Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A BALLOONING POPLITEAL PROCEDURE. DURING AN ATTEMPT TO BALLOON THE POPLITEAL AREA OF THE MALE PATIENT, THE BALLOON BURST IN A HIGHLY CALCIFIED VESSEL. WHEN REMOVING THE BALLOON, IT SNAPPED FROM THE TIP, LEAVING A PORTION OF THE BALLOON WITHIN THE PATIENT. THE VASCULAR SURGEON REMOVED THE REMAINING PART OF THE DEVICE SURGICALLY. THE PATIENTS OUTCOME IS UNKNOWN AS IT WAS NOT PROVIDED.
Patient problems: No Code Available
MAUDE report 5987478 ↗
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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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