Acrobat G47616Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00827002476165), received between Sep 21, 2017 and Jun 30, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (7 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.

• MalfunctionJun 30, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING AN ENDOSCOPIC CYSTIC GASTROSTOMY PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. IT WAS REPORTED THAT THE AXIOS INSTALLATION SYSTEM GOT STUCK AND BOTH THE AXIOS AND WIRE GUIDE ASSEMBLY HAD TO BE REMOVED FROM THE ENDOSCOPE. THE WIRE GUIDE WAS STUCK IN THE AXIOS SYSTEM. [LOSS OF WIRE GUIDE ACCESS]. A PICTURE OF THE DEVICE SHOWING WIRE GUIDE COATING DAMAGE WAS PROVIDED. [SUBJECT OF REPORT] 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22367931 ↗
• MalfunctionAug 2, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. THE USER REPORTS, AT THE TIME OF BEING [BEGINNING] IN THE PROCEDURE AND MAKING THE MOVEMENTS WITH THE WIRE GUIDE, THE USER OBSERVED ON THE WIRE GUIDE THAT THE COVER OF THE TIP IS DOWN [COATING DAMAGE AT TIP]. IT WAS APPROXIMATELY AT 6 CM OF THE TIP OF THE GUIDE. SO THEY REJECTED THE GUIDE WIRE FOR ANOTHER NEW ONE. NO COMPLICATIONS IN THE PATIENT. NO PART OF THE DEVICE IS INSIDE THE PATIENT. THEY USED ANOTHER MANUFACTURER'S WIRE GUIDE. 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 8856515 ↗
• MalfunctionApr 18, 2019Peeled/Delaminated; Off-Label Use; Improper or Incorrect Procedure or Method; Peeled/Delaminated; Off-Label Use; Improper or Incorrect Procedure or Method

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. THE WIRE GUIDE WAS PLACED THROUGH AN EUS (ENDOSCOPIC ULTRASOUND) 19 GAUGE ACCESS NEEDLE FOR A RENDEZVOUS CASE TO GET INTO THE PANCREATIC DUCT [OFF LABEL]. AFTER ACCESS WAS ACHIEVED, THE NEEDLE WAS REMOVED AND THEY TRIED TO PLACE A SOEHENDRA BILIARY DILATION CATHETER OVER THE WIRE GUIDE AND IT WOULD NOT GO OVER THE WIRE GUIDE BECAUSE THE WIRE GUIDE HAD STRIPPED. THEY HAD TO ABANDON THE CASE. THE WIRE GUIDE STRIPPED AROUND THE 10 CM TO THE 6 CM MARK. 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 8529147 ↗
• MalfunctionAug 14, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. THE PHYSICIAN USED THE 10 FR. STENT FIRST. HE FOUND IT WAS VERY HARD TO PUSH INTO THE COMMON BILE DUCT. HE WANTED TO CHANGE TO THE 7FR. STENT, BUT HE FOUND THE STENT WAS BITE SERIOUSLY WITH AWG2 [THE WIRE GUIDE WAS STUCK IN THE STENT]. THE PHYSICIAN PULLED BACK ALL OF THE SYSTEM [LOST WIRE GUIDE ACCESS] (SUBJECT OF THIS REPORT) AND USED ANOTHER MANUFACTURES WIRE GUIDE AND A 7FR STENT AGAIN. THEN IT WAS OKAY. THE PICTURE PROVIDED BY THE USER SHOWED THERE WAS COATING DAMAGE IN THE BODY OF THE WIRE GUIDE. 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 7782039 ↗
• MalfunctionJun 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. THE FOLLOWING WAS INITIALLY REPORTED: THE WIRE BENT WITHIN THE PROCEDURE AND PERFORATED THE PAPILLA LATERALLY [FROM THE INSIDE]. THE FOLLOWING FURTHER INFORMATION WAS RECEIVED REGARDING THIS EVENT: THE PAPILLA WAS LIFTED WITH THE SPHINCTEROTOME AND CANNULATED WITH THE WIRE GUIDE. THE WIRE WAS ADVANCED UNDER FLUOROSCOPY, AND THEN IT ¿SNAPPED INTO A LOOP¿ AND PERFORATED THE PAPILLA FROM THE INSIDE. CANNULATION WAS DIFFICULT AND THE PATIENT HAD A DIVERTICULUM NEAR THE PAPILLA. THE PATIENT ALSO HAD STONES THAT CAUSED DIFFICULTY WITH CANNULATION. THERE WAS NO INTERVENTION OR ADDITIONAL PROCEDURES PERFORMED DUE TO THE PERFORATION. THE PERFORATION WAS A ¿MICROPERFORATION¿ AND IT DID NOT REQUIRE ANY FURTHER TREATMENT, HEMOSTASIS, OR OTHER PROCEDURES. THE PHYSICIAN IS UNSURE IF THE TIP OF THE WIRE GUIDE CAME THROUGH TO THE DUODENUM AND FULLY PERFORATED THE TISSUE. THE PHYSICIAN¿S THOUGHTS ARE THAT THE MICROPERFORATION WOULD HAVE HAPPENED WITH ANY WIRE GUIDE, DUE TO THE PATIENT¿S CONDITIONS (DIVERTICULUM, STONES, AND AGED TISSUE). THE PHYSICIAN ALSO REPORTED THAT T

  Patient problems: Perforation

  MAUDE report 7589926 ↗
• MalfunctionMay 15, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. THE WIRE STRIPPED DURING THE LAST BALLOON SWEEP. PART OF THE WIRE DETACHED. THEY COMPLETED THE REST OF THE PROCEDURE, INCLUDING A BALLOON CHOLANGIOGRAM, WITH ANOTHER WIRE (COOK TRACER METRO DIRECT WIRE GUIDE). THE WIRE FRAGMENT WAS THEN RETRIEVED WITH COOK CAPTURA BIOPSY FORCEPS. BASED ON THE PICTURE PROVIDED AND THE ADDITIONAL QUESTIONS ANSWERED, A PIECE OF THE WIRE GUIDE COATING DETACHED IN THE SMALL BOWEL.

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

  MAUDE report 7514438 ↗
• MalfunctionFeb 23, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. DURING THE ACROBAT 2 TRIALS, THE CUSTOMER HAD A PROBLEM WITH A GUIDE WIRE. THE ERCP WAS DIFFICULT TO ACCESS, WITH A SEARCH FOR THE BILIARY DUCT FOR 35/45 MINUTES. THE FRICTION OF ANOTHER MANUFACTURER'S PAPILLOTOMY KNIFE ON THE GUIDE LINE [WIRE GUIDE] PEELED THE HYDROPHILIC PART OF THE GUIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7292076 ↗
• MalfunctionJan 29, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. THE TIP OF THE WIRE STRIPPED ABOUT 2 CM BACK FROM THE TIP WHEN TRYING TO GAIN ACCESS INTO THE PROXIMAL COMMON BILE DUCT. THE USER DID NOT NOTICE [THE COATING DAMAGE], UNTIL THE WIRE WAS PULLED OUT. THE USER THEN USED A DIFFERENT WIRE TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7226094 ↗
• MalfunctionDec 29, 2017Peeled/Delaminated; Peeled/Delaminated

  THIS FOLLOW UP REPORT IS BEING SENT TO CANCEL THE INITIAL REPORT SUBMITTED RELATED TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7155327 ↗
• MalfunctionOct 27, 2017Detachment Of Device Component; Detachment Of Device Component

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. THEY HAD A HARD TIME EXCHANGING. THE WIRE WAS STICKING IN THE CATHETER (COOK TRIPLE LUMEN SPHINCTEROTOME AND COOK STENT SET). [THE USER] COULD NOT GET THE WIRE OUT OF THE ENDOSCOPE. THE TIP OF THE WIRE BROKE OFF INTO THE ENDOSCOPE. A COMPETITORS WIRE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6983076 ↗
• MalfunctionSep 21, 2017Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT 2 CALIBRATED TIP WIRE GUIDE. IT HAD A DEFORMED TIP AND THE COVER OF THE WIRE GUIDE WAS PEELED OFF 5 CM FROM THE TIP. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 9/1/2017: THE WIRE GUIDE COATING WAS BROKEN (PEELED OFF) AT AROUND 5 CM FROM THE TIP AND THE WIRE GUIDE WAS TOTALLY BENT. IT COULD NOT KEEP ITS ORIGINALLY STRAIGHT SHAPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6882188 ↗