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Advance Enforcer G35250Recalls & reported problems

Cook Incorporated · Advance Enforcer 35 Focal Force PTA Balloon Catheter · Class 2

All models of Advance Enforcer (6)

Data updated Oct 18, 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 10827002352503), received between Nov 20, 2017 and Nov 20, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 18, 2026.

Most reported problems

Device problems

  • Detachment Of Device Component1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionNov 20, 2017Detachment Of Device Component; Detachment Of Device Component

    IT WAS REPORTED THAT WHILE TESTING THE ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER WITH A SYRINGE TO OBSERVE THE PATTERN OF BURST, THE END OF THE BALLOON DETACHED FROM THE CATHETER. IT WAS NOTED THAT THE BALLOON INFLATED IN A "NON TRADITIONAL" MANNER. THE BALLOON CATHETER DID NOT COME INTO CONTACT WITH A PATIENT.

    Patient problems: No Patient Involvement

    MAUDE report 7046589 ↗

Other Catheter, percutaneous, cutting/scoring devices

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Sources and updates

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