Acrobat G47610Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002476103), received between Jun 29, 2017 and Apr 1, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2019Peeled/Delaminated; Use of Device Problem; Improper or Incorrect Procedure or Method; Peeled/Delaminated; Use of Device Problem; Improper or Incorrect Procedure or Method

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. [IT WAS] DIFFICULT TO PASS THROUGH [THE CATHETER] AND THE END PEELED OFF THE WIRE GUIDE. THE PHYSICIAN WAS USING A COOK CLASSIC ERCP CATHETER [ERCP-1-BT]. FINALLY THIS ONE [WIRE GUIDE] WAS PEELED [COATING DAMAGE]. THE PHYSICIAN USED ANOTHER WIRE GUIDE FROM ANOTHER MANUFACTURER AND IT WORKED WELL. ADDITIONAL INFORMATION WAS RECEIVED ON 19-MAR-2019 INDICATING THAT THE DAMAGE ON THE WIRE GUIDE WAS AT THE PATIENT END, 5 CENTIMETERS FROM THE 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 8471382 ↗
• MalfunctionJun 29, 2017Migration or Expulsion of Device; Use of Device Problem; Device-Device Incompatibility; Migration or Expulsion of Device; Use of Device Problem; Device-Device Incompatibility

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. THE PHYSICIAN GAINED ACCESS, HAD THE WIRE IN PLACE AND WHEN HE WENT TO REMOVE THE COOK ULTRA TAPER SPHINCTEROTOME (UTS-20), THE WIRE WOULD NOT STAY IN PLACE. IT ALL CAME BACK TOGETHER AND HE LOST ACCESS. (THE WIRE WAS USED WITH A COOK NON-COMPATIBLE DEVICE. IT WAS USED WITH A (UTS-20). THE PHYSICIAN INSISTED ON TRYING IT AND REP DID NOT ENCOURAGE THE USE OF THE DEVICE.) THE UTS-20 AND WIRE STAYED OUT. THE PHYSICIAN THEN GAINED ACCESS WITH ANOTHER MANUFACTURER'S [.035 DEVICE] AND ADVANCED WIRE THROUGH THAT AND GAINED ACCESS WITHOUT PROBLEM. HE WENT TO REMOVE THE BALLOON AND KEEP WIRE ACCESS; HOWEVER, THE [OTHER] WIRE CAME OUT AGAIN. THEY COULD NOT GET THE WIRE TO STAY IN PLACE AND IT GRIPPED WITH THE BALLOON. THE WIRE WAS KEPT VERY WET AND THE RACETRACK WAS KEPT WET AS WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6678498 ↗