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Advance G34166Recalls & reported problems

Cook Incorporated · Advance, 18LP Low Profile PTA Balloon Dilatation Catheter · Class 2

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 10827002341668), received between Mar 10, 2023 and Mar 10, 2023 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Rupture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 10, 2023Material Rupture; Material Rupture

    ADDITIONAL INFORMATION RECEIVED 13MAR2023. OMNIPAQUE 50/50 CONTRACT WAS USED DURING THE PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16521368 ↗

Other Catheter, angioplasty, peripheral, transluminal devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.