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Acrobat G47608Recalls & reported problems

Cook Incorporated · Acrobat 2 Calibrated Tip Wire Guide · 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 00827002476080), received between Mar 16, 2018 and Mar 16, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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

  • Migration or Expulsion of Device1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMar 16, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. THE PHYSICIAN USED THE WIRE GUIDE WITH ANOTHER MANUFACTURER¿S EXTRACTION BALLOON. THE PHYSICIAN FELT THAT THE EXTRACTION BALLOON WAS PULLING ON THE WIRE AS HE WAS TRYING TO PERFORM A STONE EXTRACTION. THE WIRE CAME OUT OF THE DUCT AND ACCESS WAS LOST. THEY WERE ABLE TO RECANNULATE THE DUCT AND REGAIN ACCESS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIS WIRE GUIDE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7346054 ↗

Other Endoscopic guidewire, gastroenterology-urology devices

All Endoscopic guidewire, gastroenterology-urology devices →

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