FusionRecalls & reported problems across all models

We found 24 models of Fusion by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 440 adverse event reports in the FDA's MAUDE database, received between Mar 25, 2016 and Sep 24, 2026 — classified as 11 injuries, 429 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (158 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

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

Fusion recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 22, 2023Open, Classified

   Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).

   Z-2253-2023 · Root cause: Process control · Recall details · FDA record ↗

2. Jun 22, 2023Open, Classified

   Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).

   Z-2252-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported Fusion problems

Fusion models

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

• Fusion G31903

  Unit, electrosurgical, endoscopic (with or without accessories)
  139 reports
• Fusion G34693

  Unit, electrosurgical, endoscopic (with or without accessories)
  70 reports
• Fusion G55814

  Unit, electrosurgical, endoscopic (with or without accessories)
  58 reports
• Fusion G48278

  DISLODGER, STONE, BASKET, URETERAL, METAL
  1 recall7 reports
• Fusion G48277

  DISLODGER, STONE, BASKET, URETERAL, METAL
  1 recall3 reports
• Fusion G31911

  Unit, electrosurgical, endoscopic (with or without accessories)
  41 reports
• Fusion G34601

  Unit, electrosurgical, endoscopic (with or without accessories)
  22 reports
• Fusion G31533

  Unit, electrosurgical, endoscopic (with or without accessories)
  16 reports
• Fusion G31537

  CATHETER, BILIARY, SURGICAL
  15 reports
• Fusion G56103

  Unit, electrosurgical, endoscopic (with or without accessories)
  14 reports
• Fusion G48676

  Unit, electrosurgical, endoscopic (with or without accessories)
  9 reports
• Fusion G31532

  CATHETER, BILIARY, DIAGNOSTIC
  8 reports
• Fusion G31522

  Endoscopic guidewire, gastroenterology-urology
  6 reports
• Fusion G34711

  Unit, electrosurgical, endoscopic (with or without accessories)
  6 reports
• Fusion G31531

  CATHETER, BILIARY, DIAGNOSTIC
  4 reports
• Fusion G31905

  DISLODGER, STONE, BILIARY
  4 reports
• Fusion G31539

  Unit, electrosurgical, endoscopic (with or without accessories)
  3 reports
• Fusion G55815

  Unit, electrosurgical, endoscopic (with or without accessories)
  3 reports
• Fusion G57301

  Unit, electrosurgical, endoscopic (with or without accessories)
  3 reports
• Fusion G31529

  CATHETER, BILIARY, DIAGNOSTIC
  2 reports
• Fusion G31538

  CATHETER, BILIARY, SURGICAL
  2 reports
• Fusion G48675

  Unit, electrosurgical, endoscopic (with or without accessories)
  2 reports
• Fusion G50976

  Endoscopic guidewire, gastroenterology-urology
  2 reports
• Fusion G31910

  Endoscopic guidewire, gastroenterology-urology
  1 report

Recent Fusion adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Deflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882444 ↗
• MalfunctionAug 17, 2026Break

  During an endoscopic retrograde cholangiopancreatography (ERCP) procedure, the physician used a Cook Fusion Wire Guide Locking Device. It was initially reported that there was a product failure. There was no reportable information at this time.On 21 Jul 2026 additional information was received stating that when securing the wire guide, one of the arms of the device broke. Then they use another Wire Guide Locking Device. "[Unable to lock 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 50280010 ↗
• MalfunctionAug 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50279912 ↗
• MalfunctionAug 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50279833 ↗
• MalfunctionJul 1, 2026Detachment of Device or Device Component

  DURING COLON POLYP REMOVAL, THE PHYSICIAN USED A COOK ACUJECT VARIABLE INJECTION NEEDLE. IT WAS REPORTED THAT THE PHYSICIAN ADVANCED THE NEEDLE INTO ENDOSCOPE WORKING CHANNEL TO LESION AREA, THE PHYSICIAN PLANNED TO INJECT BUT NO RESPONSE FROM NEEDLE TIP. THE HANDLE HAD DETACHED FROM THE NEEDLE. [UNABLE TO INJECT] 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 25678192 ↗
• MalfunctionJun 17, 2026Material Split, Cut or Torn

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY TO REMOVE COMMON BILE DUCT STONES, THE PHYSICIAN USED A COOK FUSION LITHOTRIPSY EXTRACTION BASKET. IT WAS REPORTED THAT THERE WAS AN IMPACTED STONE, SO THEY DECIDED TO USE A COOK FUSION BASKET TO REMOVE IT. THIS THEN GOT IMPACTED AND THEY USED THE EMERGENCY LITHOTRIPTER TO REMOVE IT BUT UNFORTUNATELY THIS FRACTURED AND THEY WERE UNABLE TO REMOVE IT. THE PATIENT THEN HAD TO GO FOR EMERGENCY SURGERY TO REMOVE THE BASKET.

  Patient problems: Foreign Body In Patient

  MAUDE report 25537356 ↗
• MalfunctionMay 22, 2026Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS REPORTED THAT THE DEVICE BROKE DURING AN ERCP. THE CUTTING WIRE DETACHED FROM THE TIP. THE TOME WAS THROWN AWAY. NO ADVERSE COMPLICATIONS FOR THE PATIENT. A NEW TOME WAS OPENED TO FINISH 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 25255497 ↗
• MalfunctionMay 11, 2026Deflation Problem

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. IT WAS REPORTED [THAT] THE BALLOON INFLATED NORMALLY, BUT IT WAS IMPOSSIBLE TO DEFLATE IT DESPITE SEVERAL ATTEMPTS BY DIFFERENT STAFF MEMBERS (NURSES AND PHYSICIANS). THE BALLOON REMAINED INFLATED AND VERY HARD. FINALLY, AFTER AN HOUR, THE NURSE TRIED AGAIN TO DEFLATE IT, AND THIS TIME IT WORKED. IT WAS TAKEN DEFLATED TO THE PHARMACY, AND THE PROBLEM WAS NO LONGER OBSERVED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135491 ↗
• MalfunctionMay 8, 2026Sharp Edges

  DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION LITHOTRIPSY EXTRACTION BASKET. IT WAS INITIALLY REPORTED THAT THE BASKET WILL NOT PASS THROUGH THE CHANNEL AT ALL, UPON REMOVING THE BASKET IT LOOKED LIKE THERE WAS EXTRA MATERIAL ON THE SIDE OF THE CATHETER. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE RETURNED ON (B)(6) 2026 AND THE ORANGE WIRE GUIDE CHANNEL WAS DAMAGED AT THE PATIENT END [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 25125770 ↗
• MalfunctionApr 27, 2026Accessory Incompatible; Sharp Edges

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE DUODENAL PAPILLA, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS REPORTED THAT DURING THE USE OF THE DEVICE, THE CUTTING WIRE BROKE, WHICH OCCURRED AFTER SUCCESSFUL INTUBATION BUT BEFORE THE STENT WAS PLACED. THE WIRE GUIDE CAME OUT FROM ANOTHER PORT INSTEAD OF THE WIRE GUIDE PORT. 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 25000058 ↗
• MalfunctionApr 24, 2026Accessory Incompatible; Sharp Edges

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS INITIALLY REPORTED THAT THE CUTTING WIRE TIP WAS DAMAGED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. PER OUR EVALUATION OF THE RETURNED DEVICE ON (B)(6) 2026, THE TIP OF THE CATHETER/WIRE GUIDE LUMEN IS DAMAGED AND THERE IS A BURR STICKING OUT. [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 24980769 ↗
• MalfunctionApr 20, 2026Separation Failure

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. IT WAS REPORTED THAT IT WAS REALLY CHALLENGING TO SPLIT THE CATHETER. THEY [PHYSICIAN AND CREW] WERE EVENTUALLY ABLE TO SPLIT IT WITH EXTREME EFFORT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. 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 24924221 ↗
• MalfunctionApr 17, 2026Accessory Incompatible; Use of Device Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION WIRE GUIDE LOCKING DEVICE. IT WAS REPORTED THAT THE DEVICE FELL APART DURING USE. THE SPONGE AND SEALS ALL CAME APART FROM THE PLASTIC HANDLE. THE SPONGE FELL DOWN THE SCOPE AND INTO THE PATIENT [SUBJECT OF REPORT]. THEY HAD TO FISH THE SPONGE OUT OF THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THE FOAM PIECE FELL DOWN THE SCOPE AND INTO THE PATIENT. IT WAS NOT SPECIFIED HOW IT WAS RETRIEVED, BUT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24912981 ↗
• MalfunctionApr 9, 2026Deflation Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR STONE EXTRACTION IN THE COMMON BILE DUCT, THE PHYSICIAN USED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. IT WAS REPORTED THAT THE BALLOON COULD NOT DEFLATE ONCE IN THE BILE DUCT. 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 24835354 ↗
• MalfunctionMar 24, 2026Deflation Problem

  IN PREPARATION FOR A BILE DUCT STONE REMOVAL PROCEDURE, THE USER SELECTED A COOK FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING. IT WAS REPORTED THAT DURING PREPARATION, THE BALLOON WAS OBSERVED TO BE UNABLE TO DEFLATE, AND THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED USING A NEW COOK FS-8.5-12-15-B DEVICE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24679473 ↗

Other Cook Incorporated products

• Torcon NB79 models · 36 reports · 68 recalls
• Flexor134 models · 1,437 reports · 3 recalls
• Instinct5 models · 1,289 reports · 1 recall
• Saeed15 models · 863 reports
• Advance206 models · 816 reports
• Gunther Tulip5 models · 807 reports
• Hemospray2 models · 535 reports · 4 recalls
• NCircle10 models · 725 reports