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Acrobat G32758Recalls & reported problems

Cook Incorporated · Acrobat 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 00827002327580), received between Oct 7, 2016 and Oct 7, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Peeled/Delaminated” (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

  • Peeled/Delaminated1

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.

  • MalfunctionOct 7, 2016Peeled/Delaminated; Peeled/Delaminated

    ON 09/08/2016, WE RECEIVED THE FOLLOWING INFORMATION FROM THE SALES REP: DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THIS WIRE GUIDE WAS USED WITH A COOK FUSION OMNI-TOME. PER THE SALES REPRESENTATIVE, "THERE WAS NO PROBLEM WITH THE ACROBAT WIRE GUIDE, JUST A COMPLAINT WITH SPHINCTEROTOME." ON 09/12/2016, WE RECEIVED THE DEVICE AT COOK ENDOSCOPY FOR EVALUATION. THERE IS COATING DAMAGE AT THE DISTAL END OF THE DEVICE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6010531 ↗

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.