Acrobat G34265Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00827002342651), received between May 20, 2016 and Jan 4, 2019 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2019Peeled/Delaminated; Positioning Problem; Peeled/Delaminated; Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) ACROBAT CALIBRATED TIP WIRE GUIDES. THE BILE DUCT WAS CANNULATED WITH A WIRE GUIDE. IT WAS NOTICED THAT THE COATING HAD COME OFF THE WIRE GUIDE [COATING DAMAGE]. DEVICES WERE REMOVED [LOSS OF WIRE GUIDE ACCESS] AND NEW DEVICES WERE USED. IT WAS THEN NOTICED THAT THE SECOND WIRE GUIDE ALSO STRIPPED [COATING DAMAGE]. THE SECOND WIRE GUIDE WAS REMOVED [LOSS OF WIRE GUIDE ACCESS] AND ANOTHER WIRE GUIDE WAS USED. 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 8219287 ↗
• MalfunctionJun 21, 2017Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. AFTER CANNULATING, PERFORMING A SPHINCTEROTOMY, CYTOLOGY BRUSHING, AND A BALLOON SWEEP, UPON PULLING THE BALLOON OUT OF THE PATIENT, THE USER NOTICED ON THE WIRE GUIDE THE COATING HAD COME OFF; THE COATING WAS KINKED ON THE GUIDEWIRE. THE COATING STAYED ON THE WIRE AND NO PORTION OF THE COATING REMAINED IN THE PATIENT. ANOTHER WIRE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6658093 ↗
• MalfunctionJun 12, 2017Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE COATING DETACHED FROM THE ACROBAT WIRE GUIDE AFTER CANNULATION WHICH MADE EXCHANGE OF DEVICES IMPOSSIBLE.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6633072 ↗
• MalfunctionFeb 20, 2017Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE WIRE GUIDE STRIPPED AROUND THE 10 CM MARK. THE WIRE WAS REMOVED AND THE CASE WAS COMPLETED WITH ANOTHER MANUFACTURER'S WIRE GUIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6343059 ↗
• MalfunctionJan 6, 2017Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE (ACRO-35-60). AS REPORTED TO CUSTOMER RELATIONS, "PATIENT WAS GETTING ERCP WITH EXISTING UNCOVERED METAL STENT IN THE MID BILE DUCT. PROCEDURE STARTED WITH COOK QUATTRO EXTRACTION BALLOON AND THE DESCRIBED WIRE GUIDE [ACRO-35-260]. AFTER SEVERAL BALLOONS SWEEPS AND CHOLANGIOGRAMS, IT WAS DETERMINED A DISTAL BILE DUCT STRICTURE WAS OCCURRING AND A BALLOON DILATION WITH A 8 MM COOK TITAN DILATION BALLOON WAS USED. AT THAT POINT, THE FACILITY WENT UP WITH THE EXTRACTION BALLOON OVER THE SAME WIRE TO MEASURE TO PLACE A FULL COVERED STENT. AT THIS POINT, THE EXTRACTION BALLOON AND A GORE VIABIL STENT WAS PLACED OVER THE WIRE. IT WAS DETERMINED THE STENT COULD NO LONGER BE ADVANCED OVER THE WIRE BECAUSE THE HYDROPHILIC COATING ON THE WIRE STRIPPED. THIS OCCURRED AROUND THE 20 CM MARK. THERE WAS A LONG A SEGMENT WHERE THE HYDROPHILIC COATING DETACHED FROM THE CORE [COATING DAMAGE]. TO COMPLETE THE PROCEDURE, ANOTHER MANUFACTURERS WIRE GUIDE WAS OPENED AND LOADED THROUGH THE VIABIL STENT. CANNULATION WAS ACHIEVED WITH THE STENT AND THE DEPLOYMENT WAS CONTINUED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6228572 ↗
• MalfunctionDec 5, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE WIRE GUIDE'S HYDROPHILIC COATING BEGAN STRIPPING WHEN USING A BALLOON DURING A BALLOON SWEEP [COATING DAMAGE].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6144479 ↗
• MalfunctionNov 29, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. AS REPORTED TO CUSTOMER RELATIONS: "AFTER THE CASE WAS COMPLETED, THE COATING WAS NOTED TO BE SEPARATED, RIGHT AT THE 15 CM MARKER. THERE WAS NO HARM TO THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6131697 ↗
• MalfunctionOct 24, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. ON (B)(6) 2016, THE PACKAGING FOR A COOK ACRO-35-260 DEVICE WAS RECEIVED. THE DEVICE ITSELF WAS NOT RECEIVED. THERE WAS NO COMPLAINT REPORTED FROM THIS FACILITY FOR AN ACRO-35-260 OF THE SAME LOT NUMBER. AFTER FOLLOWING UP WITH THE COOK SALES REPRESENTATIVE ON THE RECEIVED DEVICE PACKAGING, SHE REPORTED THE FOLLOWING ON (B)(6) 2016: "I CAN'T REMEMBER SENDING AN ACRO-35-260 BUT IT MAY BE POSSIBLE THAT THERE WAS ONE IN THE COMPLAINTS BAG WHICH I COULD OF FORGOTTEN ABOUT WITH A SPHINCTEROTOME. THE LAST COMPLAINTS I SENT FROM THIS FACILITY WERE IN TWO OVERSIZED ORANGE BIOHAZARD BAGS (LIKE BIN BAGS) TIED UP. IF THIS IS THE CASE, THEN THE ACROBAT WIRE GUIDE COATING WOULD OF STARTED STRIPPING AS THIS HAS HAPPENED A FEW TIMES AT THIS HOSPITAL. I WILL COMPLETE A PRODUCT COMPLAINT FORM [FOR THIS DEVICE]." ON 10/05/2016, WE RECEIVED THE FOLLOWING INFORMATION FROM THE SALES REPRESENTATIVE CONFIRMING THAT THERE WAS A COMPLAINT ON THE DEVICE: "STAFF INSERTED THE ACRO-35-260 DOWN THE COOK FUSION OMNI-TOME SPHINCTEROTOME TO SEE IF THE WIRE GUIDE WOULD ENTER THE BILE DUCT EA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6050544 ↗
• MalfunctionSep 2, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. A COOK FUSION OMNI-TOME WAS USED WITH THE WIRE GUIDE TO ACCESS THE COMMON BILE DUCT. AN EXCHANGE WAS MADE FOR A COOK FUSION QUATTRO EXTRACTION BALLOON. BALLOON SWEEPS WERE MADE. THE INITIAL SWEEPS WERE MADE WITHOUT DIFFICULTY. THE TEAM BEGAN TO FEEL RESISTANCE WHEN MAKING BALLOON SWEEPS. THEN, THEY WERE NO LONGER ABLE TO MAKE BALLOON SWEEPS AND HAD TO REMOVE BOTH THE WIRE GUIDE AND THE BALLOON. WHEN THE WIRE GUIDE WAS INSPECTED AFTER REMOVAL, THE COATING OF THE ACROBAT WAS NOTED TO HAVE FOLDED BACK ONTO ITSELF. THE PROCEDURE WAS COMPLETED BY OPENING A NEW WIRE GUIDE, AND STARTING OVER TO ACCESS THE COMMON BILE DUCT AND FINISHING BALLOON SWEEPS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5924919 ↗
• MalfunctionJun 3, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE WIRE GUIDE WAS USED DURING LONG PROCEDURE IN A COOK FUSION OMNI-TOME, AND INCLUDED MULTIPLE BALLOON TRAWLS. HOWEVER, ON INSERTION OF 7 CM DOUBLE PIGTAIL STENT, THE COATING OF THE WIRE GUIDE STRIPPED, MEANING THE STENT COULD NOT BE DEPLOYED. RECANNULATION WAS ACHIEVED WITH A COOK FUSION OMNI-TOME PRELOADED SPHINCTEROTOME AND SECOND PIGTAIL STENT WAS INSERTED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5697208 ↗
• MalfunctionMay 20, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. A "FUSION OMNI-TOME WITH ACROBAT WIRE [WAS USED]. [THE PHYSICIAN] USED A [COOK] TITAN BALLOON, EXTRACTION BALLOON AND FLOWER BASKET OVER IT. DIFFICULT PUTTING DEVICES OVER. NOTICED WIRE STRIPPED WHILE PLACING PLASTIC STENT. STENT WAS DEPLOYED AND COATING CAME OFF ATTACHED TO A [COOK] FUSION OASIS. THE ORIGINAL STENT WAS ABLE TO BE PLACED. [THE] PROCEDURE WAS COMPLETED." ADDITIONAL INFORMATION WAS RECEIVED ON 04/29/2016: "THE COATING THAT RIPPED OFF WAS STUCK BETWEEN THE TIP OF [COOK] FUSION OASIS AND SHORT WIRE EXIT PORT AS THE DOCTOR PULLED THE WIRE OUT OF THE DEVICE. "

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5669457 ↗