Acrobat G47615Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002476158), received between Jun 16, 2017 and Mar 31, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Mechanical Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. DURING A DISCUSSION THE PHYSICIAN REGARDING THE ACROBAT 2 DEVICE AND THE COOK SURETOME (CAPTURED IN MDR 1037905-2026-00106), THE PHYSICIAN DISCUSSED MANY ASPECTS OF ERCP TECHNIQUES AND CONSIDERATIONS. HE MENTIONED NEAR THE END OF THE VISIT AN INSTANCE IN WHICH HE WAS USING A WIRE GUIDE, WHICH PERFORATED THE LIVER DUCT. HE SAID IT WAS STIFFER THAN HE EXPECTED AND IT JUST "SAILED OUT". HE ALSO SAID IT DIDN'T "KNUCKLE" LIKE HE EXPECTED (WHICH WE INTERPRET AS ROTATING OR ORIENTING THE TIP). UPON FURTHER DISCUSSION, IT WAS DETERMINED THAT THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR 1037905-2026-00106 FOR THE COOK SURETOME. THIS MDR IS BEING SENT TO CAPTURE THE COOK ACROBAT 2, SINCE IT WAS NOT ORIGINALLY REPORTED BY THE INITIAL REPORTER AND IT IS UNABLE TO BE DETERMINED WHICH DEVICE CAUSED OR CONTRIBUTED. THE PATIENT WILL REQUIRE A SECOND ERCP TO RETRIEVE THE PLASTIC STENT THAT WAS PLACED. THERE WAS AN INTRAHEPATIC DUCTAL PERFORATION NOTED ON FLUORO WHERE THE WIRE TERMINATED.

  Patient problems: Perforation

  MAUDE report 24744617 ↗
• MalfunctionApr 13, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED FIVE (5) TOTAL ACROBAT 2 CALIBRATED TIP WIRE GUIDES FROM LOT W3994086 [SUBJECT OF THIS REPORT] AND W3926765 [SEE RELATED MDR 1037905-2018-00144]. THE QUANTITY FROM EACH LOT IS UNKNOWN. THE WIRE WAS INSERTED AND THE PLASTIC COATING WAS UNRAVELING AND GETTING STUCK WITHIN THE ENDOSCOPE. THE USER TRIED NUMEROUS TIMES AND THE SAME THING WAS HAPPENING. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 03/29/18: THE COATING ON FIVE (5) OF THEIR WIRES SHREDDED FROM THE 5 CM MARK UPWARDS. THEY KEPT TWO (2) OUT OF THE FIVE (5) TO BE RETURNED. THE DOCTOR COULD NOT CONFIRM THAT THE TIP WAS WET BEFORE ENTERING THE SPHINCTEROTOME AND THE NURSES WERE NOT AVAILABLE TODAY TO SEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7428735 ↗
• MalfunctionAug 10, 2017Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. THE WIRE STRIPPED WHEN PLACING A LONG COOK 7-15 ZIMMON PANCREATIC STENT IN THE BILE DUCT. THE PHYSICIAN USED EXTREME FORCE TO GET THE WIRE INSIDE STENT WHEN RELEASING THE STENT. ANOTHER MANUFACTURER'S EXTRACTION BALLOON WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6785096 ↗
• MalfunctionJun 30, 2017Peeled/Delaminated; Improper or Incorrect Procedure or Method; Peeled/Delaminated; Improper or Incorrect Procedure or Method

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE (AWG2-35-260-A). DURING AN ERCP WITH DIFFICULT ANATOMY, THE PHYSICIAN WAS UTILIZING THE AWG2-35-260-A THROUGH THE COOK FUSION OASIS ONE ACTION STENT INTRODUCTION SYSTEM FS-OA-8.5. THE PHYSICIAN REQUESTED THE NURSE FOR BACK TENSION. AS THE WIRE GUIDE WAS STILL ENGAGED, THE DISTRICT MANAGER CAUTIONED THE USER OF THE INSTRUCTIONS FOR USE FOR THE FS-OA-8.5. THE GUIDEWIRE BECAME STUCK BETWEEN THE FS-OA-8.5'S GUIDE CATHETER AND PUSHER. ONCE THE DEVICES WERE REMOVED, IT WAS NOTED THAT THE COATING ON THE WIRE HAD ACCORDIONED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6680699 ↗
• MalfunctionJun 16, 2017Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. THE WIRE WAS DIFFICULT TO REMOVE THROUGH A DEVICE AND THE NURSE TRIED TO PULL WITH THE HEMOSTAT. THE COATING ON THE WIRE STRIPPED. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED ON 5/30/17 FROM THE COOK AREA REPRESENTATIVE: THERE WAS DAMAGE TO THE WIRE GUIDE AT BOTH ENDS OF THE WIRE. I DON'T KNOW EXACTLY HOW MANY CENTIMETERS AT PATIENT END AND I WOULD ESTIMATE APPROXIMATELY 5 CM. IT LOOKED ACCORDION LIKE TO MY EYE WHICH DISTORTS AN ESTIMATE. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED ON 6/7/17 FROM A PHONE CALL WITH THE COOK AREA REPRESENTATIVE: AFTER THE NURSE PULLED OUT THE WIRE GUIDE WITH THE HEMOSTAT, THE AREA REPRESENTATIVE NOTICED THE DAMAGE ON THE PROXIMAL END OF THE WIRE GUIDE. SHE THEN PUT THE WIRE GUIDE IN THE POUCH TO BE RETURNED TO COOK. A LITTLE LATER, WHILE THE PHYSICIAN WAS DOING BIOPSIES, THE PHYSICIAN HANDED HER [THE AREA REPRESENTATIVE] A PIECE OF WIRE GUIDE COATING THAT SEEMED TO HAVE BEEN RETRIEVED FROM THE BIOPSY PROCESS [THE WIRE GUIDE COATING WAS INADVERTENTLY RETRIEVED WHILE TAKING A BIOPSY]. THIS PIECE WAS ALSO PLACED IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6647268 ↗