Acrobat G47617Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002476172), received between Jul 23, 2018 and Dec 9, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (5 reports).

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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2019Positioning Problem; Positioning Problem

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. AN ENDOSCOPE WAS INSERTED AND THE USER OBSERVED A 7FR PRE-EXISTING STENT [[REFERENCE PRODUCT NUMBER (RPN), MANUFACTURER UNKNOWN] IN THE COMMON BILE DUCT. THEN THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CATHETER [RPN AND MANUFACTURER UNKNOWN] WAS ADVANCED ASIDE OF THE STENT IN THE COMMON BILE DUCT. AFTER THAT THE ERCP CATHETER WAS REMOVED WHILE THE COOK WIRE GUIDE [AWG2-35-450-A] REMAINED THERE. A PAIR OF FORCEPS WAS THEN ADVANCED TO THE STENT AND THE PHYSICIAN ATTEMPTED TO GRASP THE STENT WITH THE FORCEPS BUT HE FELT STRONG RESISTANCE, SO HE REMOVED THE FORCEPS, THE STENT, AND THE WIRE TOGETHER TO OUTSIDE THE BODY [LOST WIRE GUIDE ACCESS, SUBJECT OF THIS REPORT]. THE USER CHECKED THE WIRE AND FOUND THAT THE COATING MATERIAL OF THE COOK WIRE GUIDE [AWG2-35-450-A] CAME OFF. THE PROCEDURE WAS COMPLETED WITH AN ANOTHER MANUFACTURERS WIRE GUIDE AND THE STENT REPLACEMENT WAS COMPLETE. 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 NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9438873 ↗
• MalfunctionDec 6, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. THE DEVICE WAS ADVANCED OVER ANOTHER MANUFACTURERS ERCP CATHETER, AFTER REMOVING THE CATHETER, A CONTRAST TUBE THAT DOES NOT HAVE METAL TIPS, WAS ADVANCED OVER THE COMPLAINT WIRE GUIDE. AFTERWARD, THE PHYSICIAN ACCESSED THE STRICTURE WITH THE COMPLAINT WIRE GUIDE BUT COULD NOT PASS THROUGH THE STRICTURE. THE OPERABILITY OF THE WIRE GUIDE WAS NOT GOOD AND THE TIP OF THE WIRE GUIDE WAS GRADUALLY DEFORMED, SO THEY PHYSICIAN CANCELLED USING IT. AFTER REMOVING THE COMPLAINT WIRE GUIDE FROM THE PATIENTS BODY, HE CONFIRMED THAT THE COATING MATERIAL OF THE WIRE GUIDE PEELED OFF. 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 9434203 ↗
• MalfunctionAug 26, 2019Peeled/Delaminated; Off-Label Use; Peeled/Delaminated; Off-Label Use

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. THE ACROBAT® 2 WIRE GUIDE WAS COMBINED WITH ANOTHER MANUFACTURER'S METAL TIP CATHETER PRIOR TO INSERTION INTO ENDOSCOPE. THEN, THE TWO DEVICES AS A UNIT WERE ADVANCED THROUGH THE ENDOSCOPE TO THE PAPILLA FOR ERCP. THE USER WAS EXPLORING THE BILE DUCT WITH MANIPULATING THE WIRE GUIDE SEVERAL TIMES IN ORDER TO INSERT THE UNITE DEVICES INTO THE BILE DUCT THOUGH, HE FAILED. HE REMOVED ONLY THE WIRE GUIDE TO CHANGE THE ERCP CATHETER, THEN HE NOTICED THAT THE COATING MATERIAL OF THE WIRE GUIDE WAS PEELED-OFF AT APPROXIMATELY 5 CM FROM THE TIP. ANOTHER ACROBAT® 2 WIRE GUIDE WAS USED INSTEAD. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. 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 8931399 ↗
• MalfunctionAug 2, 2019Positioning Problem; Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. PROCEDURE FOR REPLACING A BILE DUCT STENT WAS PERFORMED. WIRE-GUIDED-CANNULATION WAS PERFORMED FROM THE SIDE OF THE STENT WITH THE WIRE GUIDE AND ANOTHER MANUFACTURER'S ERCP CATHETER. THE ERCP CATHETER DID NOT HAVE A METAL TIP. AFTER THAT, THE ERCP STENT [CATHETER] WAS REMOVED AND THE WIRE GUIDE REMAINED AT THE SIDE OF THE STENT. THEN, THE USER ATTEMPTED TO REMOVE THE STENT BUT COATING MATERIAL OF THE WIRE GUIDE PEELED OFF DURING REMOVAL OF THE STENT. ANOTHER WIRE GUIDE WAS USED INSTEAD [LOST WIRE GUIDE ACCESS] [SUBJECT OF THIS REPORT]. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. 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 8857486 ↗
• MalfunctionJul 25, 2019Peeled/Delaminated; Off-Label Use; Peeled/Delaminated; Off-Label Use

  THE FOLLOWING WAS INITIALLY REPORTED TO THE FDA: "DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. CANNULATION WAS PERFORMED WITH THE WIRE GUIDE AND ANOTHER MANUFACTURER'S ERCP CATHETER. THE ERCP CATHETER DID NOT HAVE A METAL TIP. THE WIRE GUIDE AND ANOTHER MANUFACTURER'S WIRE GUIDE WERE USED TOGETHER TO REACH THE DESIRED BRANCH OF THE INTRAHEPATIC BILE DUCT. AFTER ADVANCING THE WIRE GUIDE IN THE DESIRED BRANCH, A DIFFERENT CATHETER FROM ANOTHER MANUFACTURER WAS ADVANCED OVER THE WIRE GUIDE. DURING THE ADVANCEMENT, THE USER FELT STRONG RESISTANCE, BECAUSE THE LUMEN SIZE AROUND THE PORTA HEPATIS WAS NARROWED BY STONE(S) THEREFORE, THE USER REMOVED THE WIRE GUIDE FROM THE BODY AND HE ATTEMPTED TO PERFORM CANNULATION AGAIN BUT THE USER NOTICED ON THE ENDOSCOPE MONITOR THAT THE COATING MATERIAL OF THE WIRE GUIDE WAS BEING PEELED OFF [SUBJECT OF THIS REPORT], SO HE STOPPED USING THE WIRE GUIDE. ANOTHER MANUFACTURER'S WIRE GUIDE WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THE USER NOTED THAT DURING THE ADVANCEMENT OF THE SECOND CATHETER OVER THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8828368 ↗
• MalfunctionMay 31, 2019Peeled/Delaminated; Peeled/Delaminated

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. JUST BEFORE THE CANNULATION, THE ASSISTANT NURSE TRIED TO PUT THE WIRE INTO THE CANNULA. SOME RESISTANCE FORCE EXISTED INSIDE THE LUMEN, PER THE NURSE, AND SHE RECOGNIZED THAT THE COATING OF THE WIRE TIP WAS TAKEN OFF FROM THE BODY OF THE WIRE. SHE REMOVED THE WIRE AND USED ANOTHER OF THE SAME DEVICE AND THE CASE WAS FINISHED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8658189 ↗
• MalfunctionJul 23, 2018Peeled/Delaminated; Off-Label Use; Improper or Incorrect Procedure or Method; Peeled/Delaminated; Off-Label Use; Improper or Incorrect Procedure or Method

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. THE WIRE GUIDE PEELED WHILE BEING USE WITH A COOK ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE (ECHO-HD-19-A). THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 29-JUNE-2018: AFTER ADVANCING THE ACROBAT WIRE THROUGH THE ACCESS NEEDLE AND REACHING THE BILE DUCT, THEY NEEDED TO WITHDRAW AND MOVE THE WIRE GUIDE IN ORDER TO GAIN ACCESS TO THE PAPILLA. THIS IS WHEN THE PROBLEMS [WIRE GUIDE COATING DAMAGE] BEGAN. THE PICTURES PROVIDED BY THE USER SHOW COATING DAMAGE APPROXIMATELY 6 CM TO 17 CM FROM THE DISTAL TIP. 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 7709890 ↗