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Acrobat G44214Recalls & 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 00827002442146), received between Apr 8, 2016 and Apr 8, 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.

  • MalfunctionApr 8, 2016Peeled/Delaminated; Peeled/Delaminated

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE. HE USED THE LONG TECHNIQUE [DEVICE EXCHANGE TECHNIQUE] AFTER SPHINCTEROTOMY. WHEN THE GUIDE WIRE IS IN CDC [COMMON BILE DUCT] THE PHYSICIAN STARTED THE SPHINCTEROTOME EXCHANGE. THE GUIDE WIRE PEEL OFF THE DISTAL PART [DISTAL TIP COATING DAMAGE] AROUND 11.5 CENTIMETERS FROM THE TIP. FOR FINALIZE THE PROCEDURE [TO FINISH THE PROCEDURE], THE PHYSICIAN USED ANOTHER ACROBAT CALIBRATED TIP WIRE GUIDE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5562724 ↗

Other Endoscopic guidewire, gastroenterology-urology 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.