Acrobat G47613Recalls & 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 00827002476134), received between Sep 27, 2019 and Sep 27, 2019 — 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.
MalfunctionSep 27, 2019Peeled/Delaminated; Peeled/Delaminated
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. SEVERAL ATTEMPTS TO CANNULATE AND GAIN ACCESS WITH WERE MADE WITH THIS WIRE GUIDE AND A COOK FUSION TRIPLE LUMEN NEEDLE KNIFE BUT WERE UNSUCCESSFUL. UPON ABANDONING THE PROCEDURE, IT WAS NOTED THAT THE WIRE GUIDE FRAYED AND EXPOSED THE BARE WIRE UNDERNEATH. THE HYDROPHILIC COATING HAD STRIPPED BUT WAS FULLY INTACT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9131185 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.