AcrobatRecalls & reported problems across all models

We found 15 models of Acrobat by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 112 adverse event reports in the FDA's MAUDE database, received between Feb 26, 2016 and Mar 31, 2026 — classified as 1 injury, 111 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (95 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Acrobat problems

Acrobat models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Acrobat G34266

  Endoscopic guidewire, gastroenterology-urology
  44 reports
• Acrobat G47614

  Endoscopic guidewire, gastroenterology-urology
  16 reports
• Acrobat G34265

  Endoscopic guidewire, gastroenterology-urology
  11 reports
• Acrobat G47616

  Endoscopic guidewire, gastroenterology-urology
  11 reports
• Acrobat G47617

  Endoscopic guidewire, gastroenterology-urology
  7 reports
• Acrobat G47612

  Endoscopic guidewire, gastroenterology-urology
  6 reports
• Acrobat G47615

  Endoscopic guidewire, gastroenterology-urology
  5 reports
• Acrobat G44217

  Endoscopic guidewire, gastroenterology-urology
  3 reports
• Acrobat G32759

  Endoscopic guidewire, gastroenterology-urology
  2 reports
• Acrobat G47610

  Endoscopic guidewire, gastroenterology-urology
  2 reports
• Acrobat G32758

  Endoscopic guidewire, gastroenterology-urology
  1 report
• Acrobat G34264

  Endoscopic guidewire, gastroenterology-urology
  1 report
• Acrobat G44214

  Endoscopic guidewire, gastroenterology-urology
  1 report
• Acrobat G47608

  Endoscopic guidewire, gastroenterology-urology
  1 report
• Acrobat G47613

  Endoscopic guidewire, gastroenterology-urology
  1 report

Recent Acrobat adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionJun 3, 2025Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT¿ 2 CALIBRATED TIP WIRE GUIDE. IT WAS REPORTED THAT HE SHEATH OF THE GUIDE WIRE BECAME DETACHED FROM THE WIRE AND THAT THIS PROBABLY HAPPENED WHILE CHANGING THE ERCP CATHETER - TOO MUCH TENSION ON THE CATHETER. THE WIRE WAS SPRAYED WITH SILICONE SPRAY. 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 22135529 ↗
• MalfunctionMay 22, 2025Fracture; Peeled/Delaminated; Fracture; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT¿ CALIBRATED TIP WIRE GUIDE. DURING THE PROCEDURE THE PHYSICIAN DETECTED THE COATING OF THE WIRE GUIDE PEEL OFF [COATING DAMAGE], THEN RETRACTED THE WIRE GUIDE AND CHANGED TO A ZEBRA WIRE GUIDE TO COMPLETE THE PROCEDURE [LOSS OF WIRE GUIDE ACCESS]. 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 22072131 ↗
• MalfunctionMay 8, 2025Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT¿ CALIBRATED TIP WIRE GUIDE. IT WAS REPORTED THAT THE PHYSICIAN DETECTED THE COATING OF THE WIRE GUIDE PEEL OFF AND CHANGED TO ANOTHER ONE OF THE SAME DEVICES TO CONTINUE THE PROCEDURE. 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 21987790 ↗
• MalfunctionApr 17, 2025Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ACROBAT¿ CALIBRATED TIP WIRE GUIDE. IT WAS REPORTED THAT THE COVERING PEELS/DETACHES FROM WIRE GUIDE DURING STENT IMPLANTATION, REPLACEMENT OF WIRE GUIDE [LOSS OF WIRE GUIDE ACCESS] AND CONTINUATION OF CANNULATION AND IMPLANTATION [WAS REQUIRED]. 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 21858361 ↗
• MalfunctionApr 3, 2025Peeled/Delaminated; Peeled/Delaminated

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK ACROBAT¿ CALIBRATED TIP WIRE GUIDE. IT WAS REPORTED THAT THE PHYSICIAN OPENED THE PACKAGE AND TOOK OUT THE DEVICE AND FOUND THE HYDROPHILIC COATING BROKEN AND OFF. NOT USED ON PATIENT. AN IMAGE SHOWING THE WIRE GUIDE COATING DAMAGE WAS PROVIDED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21769973 ↗
• 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 ↗
• MalfunctionNov 25, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE USER DETECTED THE WIRE GUIDE COATING PEELED OFF DURING PROCEDURE UNDER ENDOSCOPIC VIEW. THE USER CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. THE PHOTO PROVIDED DEPICTS THE COATING DAMAGE BETWEEN 20 AND 21 CM. 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 9371320 ↗
• MalfunctionNov 19, 2019Peeled/Delaminated; Peeled/Delaminated

  PRIOR TO A ENDOSCOPIC PROCEDURE, THE PHYSICIAN OPENED A COOK ACROBAT¿ CALIBRATED TIP WIRE GUIDE FROM THE PACKAGING. IT WAS FOUND OUT THAT THE COATING OF THE WIRE GUIDE PEELED OFF. THE PHYSICIAN CHANGED TO ANOTHER COOK ACROBAT¿ CALIBRATED TIP WIRE GUIDE TO COMPLETE THE PROCEDURE. BASED ON THE PHOTO PROVIDED, THE DAMAGE APPEARS TO BE AROUND 20-25 CENTIMETERS (CM) THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9341674 ↗
• MalfunctionNov 4, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE USER FOUND OUT THE COATING OF WIRE GUIDE PEELED OFF DURING ERCP PROCEDURE. 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 9273099 ↗
• MalfunctionOct 18, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THEY PHYSICIAN USED A COOK ACROBAT® 2 CALIBRATED TIP WIRE GUIDE. THE CUSTOMER HAS STATED THAT THE HAVE HAD INCIDENT WHERE A WIRE HAS SHREDDED ITS OWN HYDROPHILIC COATING WHILST INSIDE A PATIENT. ADDITIONAL INFORMATION RECEIVED INDICATED THE COATING DAMAGE WAS AT THE PATIENT END APPROXIMATELY. 20 CM FROM TIP THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 24 SEP 2019 AND IT WAS DETERMINED THAT THERE WAS COATING DAMAGE AT THE JOINT OF THE TIP AROUND 5.85 CM 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 9208692 ↗
• MalfunctionOct 18, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE USER FOUND OUT THE SURFACE OF WIRE GUIDE PEELED OFF DURING PROCEDURE. 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 9208302 ↗
• MalfunctionOct 11, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED TWO (2) ACROBAT CALIBRATED TIP WIRE GUIDES. THE USER FOUND OUT THE SURFACE OF WIRE GUIDES PEELED OFF DURING PROCEDURE. 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 9181995 ↗

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